Findings Of Fact A. whether the "Grandfather" Issue Should Be Determined. The Petitioner, Mease Hospital and Clinic (Mease), operates a 278 bed hospital in Dunedin, a 100 bed hospital in Countryside, and a medical clinic. All are located in north Pinellas County, in the North Pinellas subdistrict of HRS District 5. In 1982, Mease applied for a certificate of need to equip and operate a cardiac catheterization laboratory (CCL). At the time, Mease was of the view that a CCL would be a new service and would therefore require a certificate of need. When Mease determined that approval would not be likely under then current rules, Mease withdrew its application because it understood that a final denial legally would preclude Mease from re-applying for three years. On July 11, 1986, the Respondent, HRS, entered a Final Order adopting a Recommended Order and acknowledging that Humana Hospital Northside, also located in Pinellas County, HRS District 5, continuously had been providing cardiac catheterization services since before July 1, 1977, the effective date of certificate of need regulation of CCLs, and therefore was not required to obtain a certificate of need for a CCL as a new service. Final Order, Humana Hospital Northside v. Department of Health, etc., 8 F.A.L.R. 3910 (DHRS July 11, 1986). When Mease reviewed the Humana Northside Final Order and final hearing transcript, it concluded that it, too, should be "grandfathered." Mease was doing the same type catheterization procedures as Humana Northside. Mease decided to re-apply for a certificate of need both on the basis of need for a CCL at Mease and on the basis of the "grandfather" claim. In October, 1986, Mease filed the pending certificate of need application. In addition to the more typical components of a CON application, the Mease application states in pertinent part: EQUIPMENT/SERVICE TYPE: Mease Hospital and Clinic maintains that the Cardiac Catheterization Program is not a new service, as procedures similar to those performed at Humana Northside, which was recently approved on a grandfathering basis for cardiac catheterization have been performed at Mease Hospital and Clinic in Dunedin for more than 20 years. * * * ADDITIONAL PROJECT DETAILS/REMARKS: Mease Hospital and Clinic believes its historic performance of procedures identical to those for which Humana Northside was grand fathered a cardiac catheterization lab is sufficient to justify similar action, resulting in approval of Mease' proposal. HRS' State Agency Action Report (SAAR) was completed in April, 1987. It evaluated the Mease proposal as a typical certificate of need application and denied it on the basis of lack of need. There was no direct mention of the "grandfather" claim, but the SAAR concludes in pertinent part: "Deny a certificate of need for [the Mease] project [among others] in its entirety... Reasons for decision: Insufficient need for an additional cardiac cath lab." Mease's petition for formal administrative proceedings on the denial does not specifically address the "grandfather" claim, either. During the pendency of this proceeding, Mease continued to seek a "grandfather" exemption apart from this proceeding. But Mease's prehearing proceedings in this case were conducted in a way that indicated its assumption that the "grandfather" issue would be determined by final agency action in this case, if not before by informal means. The other parties recognized this assumption and were not prejudiced by Mease's failure to formally specify the issue in its pending petition for formal administrative proceedings or by amendment to it. By letter dated November 23, 1987, HRS finally responded to Mease's continued efforts to obtain "grandfather" status and denied the request. Mease still did not amend its petition for formal administrative proceedings (nor did it file a new, separate petition in response to the November 23 letter.) But it continued to conduct prehearing procedures in a manner so as to have the "grandfather" claim heard as part of this case. HRS and the Intervenor, Morton Plant Hospital, Inc. (Morton Plant) first objected on the record to consideration of the "grandfather" issue in this case in the Prehearing Stipulation filed on January 6, 1988. The "grandfather" issue should be determined in this proceeding. Whether Mease Has A "Grandfathered" CCL. Before July 1, 1977, and continuously since, Mease has operated a special procedures room at its Dunedin hospital. The special procedures room is the largest room in the x-ray department, with adjoining rooms that contain sinks for sterile technique and housing computers. Equipment in the room includes an x-ray generator with a high MA capability to do moderately rapid sequence films and fluoroscope. There is a table of special design to allow movement in all directions to facilitate fluoroscopy. Three different film changers are used. The room contains a large array of catheters, wires and needles for use in the catheterization process. There is a defibrillator monitor, pressure monitors, and various physiologic monitors also in the room. Finally, there is a digital vascular imaging ("DVI") machine to facilitate the computerized processing of digital subtraction studies. The DVI machine has been used to perform coronary arteriographies. During the time the special procedures room has been operational, it has been staffed with persons specifically trained in critical care of patients, with special knowledge of cardiovascular medication and catheterization type equipment. There has always been ample support staff available for patient observation, handling blood samples, performing blood gas evaluations and monitoring physiological data. The catheterization team usually consists of the physician, a special procedures nurse (an R.N. with critical care training) and at least two dedicated radiographer technologists with special knowledge of the equipment. A special procedures log is maintained by physicians using the special procedures room. Procedures typical of those contained on the log prior to and consistently since 1977 include renal arteriograms, pulmonary arteriograms, cerebral arteriograms and femoral arteriograms. Pulmonary arteriograms involve passing a catheter through a right side chamber of the heart into the lungs; the other procedures do not involve passing a catheter into the heart. Pulmonary angiograms, right ventriculography and right atrial injections are all currently performed at Mease in the radiology laboratory. Right heart catheterization procedures are being performed in the CCU units and the special procedures lab at Mease. The special procedures room is not used by radiologists or cardiologists to do any therapeutic or diagnostic studies of the left chambers of the heart. Unlike procedures such as pulmonary arteriograms, in which the catheter is inserted into or through a chamber on the right side of the heart, fluoroscopy is required for insertion of a catheter into a chamber of the left side of the heart. With fluoroscopy, left heart catheterization procedures involve no significantly increased danger to the patient. Left heart catheterization procedures require faster film sequencing equipment for fluoroscopy because the left heart is a higher pressure (faster flow) system than the right heart chambers. Mease's cardiologists perform these procedures in a CCL at either Morton Plant or Largo Medical Center in Clearwater. The Mease special procedures room does not have, and has not had, the more sophisticated equipment needed to perform catheterization procedures in the left chambers of the heart. The sophisticated equipment needed for left heart catheterizations customarily is part of a CCL. It is commonly understood that a CCL is a laboratory which includes this equipment and uses this equipment for left heart catheterizations. Mease shared this understanding until it learned of the Final Order in Humana Hospital Northside. It never contested the omission of cardiac cath services from its hospital license, never reported cardiac cath procedures to the local health council and applied for a CON for a CCL in 1982. On review of the Humana final order and the record of the case, Mease correctly concluded that its special procedures room was being operated in the same way as Humana Northside's. Mease also concluded that it, too, was entitled to "grandfather" status. But the Humana final order points out: The respondent HRS offered no evidence to dispute the fact that petitioner has indeed been providing cardiac catheterization services on a regular and continuous basis from pre-July 1, 1977 to the present time. Instead, HRS takes the position that since petitioner never reported to the Local Health Council that it was performing such services, it is now somehow estopped from claiming a "grandfather" exemption from Certificate of Need review. There is competent and substantial evidence demonstrating that petitioner began performing cardiac catheterization procedures prior to July 1, 1977, at a time when Certificate of Need review was not required, and has continued to perform such services on a regular basis. Accordingly, petitioner was exempt from Certificate of Need review when it initiated such services and continues to maintain that exempt status so long as it regularly and continuously performs such services. In this case, there was persuasive evidence disputing that Mease has been operating a CCL. Mease's special procedures room had some, but not all, of the equipment customarily used in cardiac catheterization. Its special procedures room is not the kind of room customarily used to perform cardiac catheterization procedures. This is why Mease never before claimed entitlement to "grandfather" status but rather presumed that it did not have a CCL and would need a CON to open a CCL. Mease has not been operating a CCL continuously since July 1, 1977. Need For Mease's Proposed CCL. Mease filed the pending CON application in October, 1986. At the time, the local health council for District 5 was reporting an inventory of four CCLs: St. Anthony's; Morton Plant; Largo; and All Children's. Mease also knew that HRS had entered a final order in July, 1986, recognizing "grandfather status" for Humana Northside and allowing Humana Northside to upgrade its CCL by adding up-to-date equipment required for left heart catheterization procedures. At the time of the State Agency Action Report (SAAR) denying Mease's application in April, 1987, HRS was aware of, and also counted in the inventory at the time of the SAAR, a second CCL at Morton Plant which was added without CON review. The second Morton Plant CCL became operational in July, 1986, but was not reported to the local health council until early 1987, and was not reported by the local health council until September, 1987. A second CCL also opened without CON review at Largo Medical Center. But the evidence was not clear when the second Largo lab opened. It was not reported to, or by, the local health council before the SAAR either, and HRS did not count it in the inventory for purposes of the SAAR. Since the SAAR, two additional CCLs have been approved without CON review at Bayfront Hospital/All Children's Hospital in St. Petersburg. Finally, on November 24, 1987, the District Court of Appeal, First District, rendered an opinion reversing HRS' final order denying an application for a CON for a CCL at Bayonet Point Regional Medical Center in Pasco County in District 5. This CCL was approved for purposes of meeting the need existing as of 1986. The actual District 5 CCL use rate for the period July, 1985, through June, 1986, using local health council data, was 308.47 procedures per 100,000 population. The year in which the proposed CCL would initiate service, but not more than two years into the future, is July, 1988. The District 5 population in July, 1988, is projected to be 1,124,986. The number of procedures projected for District 5 in July, 1988, is 3470. Allocating 600 procedures per CCL, 3470 procedures would create a numerical need for 6 CCLs in District 5 in July, 1988. The local health council did not report any procedures done at the "grandfathered" CCL at Humana Northside, and none were included in the data for the time period July, 1985, to June, 1986. Counting the "grandfathered" Humana Northside CCL in the inventory at the time of the SAAR without attributing any procedures to it for purposes of calculating the use rate for July, 1985, to June, 1986, amounts to a recognition that Humana Northside, while given "grandfather" status based on the facts presented in DOAH Case No. 84-4070, was not in fact operating a CCL continuously since July, 1977. Refusal to attribute procedures to Humana Northside reflects a rational policy decision in this case not to perpetuate the error resulting from the apparently less-than-adequate HRS presentation of its case in the Humana Northside case. There was evidence officially recognized in this case without objection--namely, the Final Order, Bayonet Point Medical Center v. Department of Health and Rehabilitative Services, 8 F.A.L.R. 4342 (DHRS 1986)--that 1200 Pasco County (District 5) residents were being referred to Tampa for cardiac catheterization and open heart surgery in the year preceding June, 1986. (300 were open heart surgery patients.) But there was no evidence to prove how many of the 900 cardiac catheterization patients who were referred to Tampa in the period July, 1985, to June, 1986, would have had the procedure performed in District 5 if Bayonet Point had a CCL. It necessarily follows that there was no evidence to prove that any additional cardiac cath procedures for Pasco County patients performed in District 5 as a result of the Bayonet Pont CCL will not be absorbed by and performed at the Bayonet Point CCL. District 5 has the highest percentage of 65 and over population in the state (29.7 percent for calendar year 1986), but next to the lowest number of catheterizations per thousand of all the districts in the sate. District 5 also has a large cohort of population age 45 to 64. Over 50 percent of the population in District 5 is in the age cohort for which cardiac catheterization is most frequently needed as a diagnostic or therapeutic tool. Seasonal fluctuations increase the elderly winter population. Resident death rate from heart disease is almost 50 percent higher in District 5 than it is for the state of Florida. These factors combine to create an actual use rate in District 5 that, for the past two years (1986 and 1987) has exceeded (or, for 1987, was projected to exceed) the projected horizon year (July 1988) use rate derived from using the 1985 use rate data. The actual use rate for January through September 1987, when extrapolated for the entire calendar year of 1987, shows that the number of procedures expected to be actually performed in District 5 in 1987 is 46 percent (approximately 1,000 procedures) greater than the number of procedures projected to be needed in July 1988 using the 1985 use rate. The projection of procedures for July 1988 is 700 procedures less than actually occurred in District 5 in 1986. Use of July, 1985 to June, 1986, use rate in a demographic configuration like that found in District 5 underestimates projected procedures for July, 1988. Some trends in health care and area population growth do not support the addition of a cath lab at Mease. While the population of north Pinellas County, where Mease is located, is equal in age distribution to south Pinellas County, the new growth in north Pinellas and Pasco is younger than south Pinellas. Increased use of non-invasive diagnostic procedures, such as MRI and CAT scan, will reduce the growth of cardiac cath procedures in the future. The growth in the use rate in cardiac caths is in the number of therapeutic caths, which by rule are required to be done in a facility with open heart surgery and therefore cannot be done at Mease at this time. Indeed, the number of right heart caths being done at Mease has remained constant over the past several years. Also, death from heart disease is decreasing due to improvements in life style. All the cath labs in District 5 are within a two hour drive time of 90 percent of the population in District 5. Morton Plant is six miles from Mease Dunedin. Mease Countryside is twelve miles from Morton Plant and eight miles from Mease Dunedin. One-third of the Mease cardiologist's patients are at Mease Countryside and for catheterization these patients would have to be admitted at or transported to Mease Dunedin where the proposed lab would be located. There is sufficient capacity in the existing cath labs to serve growth in the near future. Approximately 600 more procedures could be done at Morton Plant. There is no problem scheduling caths at Morton Plant. There has been some difficulty getting beds for Mease patients before and after the procedure, but Morton Plant just opened new ICU beds with specially trained nurses to accommodate Dr. Gibbs' patients. The existing labs in District 5 are financially accessible. A significant number of the labs are located in not- for-profit hospitals that serve all types of patients. E.g., Morton Plant, which has an overlapping service district with Mease, offers twice the number of Medicaid days as Mease. In addition, as previously mentioned, new approved labs at Bayfront/ALL Children's (2) and Bayonet Point (1) will be coming on line to provide additional capacity (and bring the total number of CCLs in District 5 to ten.)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that HRS enter a final order: (1) denying Mease's request for recognition of a "grandfathered" CCL at its Dunedin hospital; and (2) denying its application for a CON for a CCL at its Dunedin hospital, CON Action No. 5108. J. LAWRENCE JOHNSTON 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 12th day of May, 1988.
The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Howard E. Gross, M.D., based on allegations that he violated Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1971 and issued license number ME 0017039. Respondent has never been disciplined previously. Respondent is board-certified in internal medicine (1970) and cardiovascular diseases (1973). He is an interventional cardiologist. He has practiced medicine in Orlando since 1971. For the past 10 years, he has done a high-volume catheterization practice. In the most recent one-year period, he did approximately 500 interventional procedures and 400 diagnostic procedure, and in almost all instances, the catheterization involved a ventriculogram. On or about February 18, 1997, patient L. D. L., an 84-year-old male with a history of coronary artery disease, presented to Orlando Regional Medical Center, for catheterization and possible rescue angioplasty to be performed by Respondent. Respondent performed a cardiac catheterization on the patient. During the catheterization procedure, Respondent advanced a 6-French pigtail catheter into the patient's left ventricle and performed a ventriculogram by injecting what he thought was approximately 20cc of ionic dye, utilizing a MEDRAD injector. During the catheterization procedure, Respondent noted that he did not obtain opacification of the left ventricle and noted that free air was in the left ventricle. In fact, Respondent injected the patient with approximately 15cc to 20cc of free air rather than dye. As a result, the patient suffered cardiac arrest, and his blood pressure fell to zero. Respondent initiated various life-saving measures to counter the effects of the injection of free air, which were unsuccessful, and the patient was pronounced dead at approximately 1:55 p.m., as a result of cardiac arrest brought on by an air embolus. At the time, Orlando Regional Medical Center (hereinafter "ORMC") had a policy/procedure (No. 3233-MEDRAD- 0001) for Cardiac Catheterization Laboratory (hereinafter "Cardiac Cath Lab") personnel (Respondent's Exhibit 1). It delineated specific procedures to ensure "the use and safe applications of the power injector." In particular, it states the procedure to be employed by Cardiac Cath Lab staff in loading the MEDRAD injector. At ORMC and other hospitals, Cardiac Cath Lab personnel load the MEDRAD injectors without physician supervision. As explained by both expert witnesses, loading the syringe with dye is a very simple task for a nurse or scrub tech to perform. In the instant case, the nurse loading the MEDRAD injector interrupted the loading procedure because she was concerned about the patient's lab values (kidney function) and was uncertain about what type of dye Respondent would order. Respondent was not yet in the Cardiac Cath Lab. The nurse anticipated asking Respondent which type of dye he wanted and then loading that type dye into the MEDRAD injector. When she interrupted the loading procedure, the nurse left the plunger positioned in the syringe where it appeared that the syringe had been loaded with 20 to 25cc of dye and the injector arm pointing upward. The nurse then left the Cardiac Cath lab to get her lead apron anticipating only a monetary absence from the lab. Unknown to her, Respondent entered the Cardiac Cath Lab within seconds after her departure. Respondent was not in the Cardiac Cath Lab at any time while the nurse was manipulating the MEDRAD injector. As the nurse secured her lead jacket, she was called to another patient to administer medication which required the presence of a registered nurse per hospital procedures. In the nurse's absence, the catheterization and ventriculogram of the patient proceeded. The Registered Cardiovascular Technician (hereinafter "RCT"), observing the MEDRAD injector in what appeared to be a prepared state, wheeled it to the patient's side and lowered the injector arm into a position to receive the catheter. The RCT testified that a MEDRAD injector would never be left as she found it, plunger at the 20 to 25cc mark and arm elevated, if the machine was not loaded with dye. The ionic dye used in the procedure is clear and, due to the nature of the MEDRAD plunger and casing, it is extremely difficult to tell if dye is in the syringe. Further compounding the difficulty in observing dye in the syringe is the fact that the lights in the Cardiac Cath Lab are lowered during the procedure to allow better visualization of the video monitor. While the RCT positioned the MEDRAD injector at the patient's side, Respondent was in the process of entering the catheter into the patient, manipulating the catheter in the patient, visualizing its position in the patient's heart on the video monitor and monitoring hemodynamics. Petitioner's expert witness testified that Respondent did justifiably rely on the Cardiac Cath Lab personnel to follow the procedure outlined in Respondent's Exhibit 1. The nurse and cardiovascular technician did not follow the policy/procedure and, as a result, allowed the presence of air in the MEDRAD injector. After the catheter is properly located in the patient's heart, the external end of the catheter is attached to the MEDRAD injector. Petitioner's expert witness opined the Respondent should have used extension tubing to effect the connection between the catheter and MEDRAD injector. Testimony revealed that extension tubing is used by many physicians who perform cardiac catheterization. Respondent's practice was not to use extension tubing. Both Petitioner's and Respondent's expert witnesses agreed that Respondent's choice not to use extension tubing was a "technique" choice and did not fall below the "standard of care." Petitioner's expert opined that Respondent should have been present in the Cardiac Cath Lab to observe the loading of the MEDRAD injector. Testimony revealed that at ORMC and other hospitals it was the Cardiac Cath Lab staff's responsibility to load the MEDRAD injector without the direct supervision of physicians and that physicians are rarely in the lab when the MEDRAD injector is loaded. The "standard of care" does not require the physician to watch the loading of dye or the expulsion of air from the syringe in the loading process. Petitioner's expert opined that Respondent should have performed a test injection (a process where a small amount of dye is injected into the heart prior to the main injection). Respondent's expert testified that under certain circumstances (none of which is applicable to the instant case) test injections were appropriate; those circumstances occur less than 5 percent of the time. Electing not to perform a test injection in the instant case does not fall below the "standard of care." Petitioner's expert opined that Respondent should have observed a "wet to wet" connection between the catheter and the MEDRAD injector to ensure that no air is in the system. This is accomplished by withdrawing a small amount of blood from the catheter into the MEDRAD injector. Small air bubbles may appear between the blood and dye and are then "tapped" to rise to the top of the syringe. However, Respondent performed the "wet to wet" connection and did not observe anything unusual. He has historically performed some "wet to wet" connections where no air bubbles were present between the blood and dye as it appeared in this case. The RCT confirmed that Respondent performed the "wet to wet" connection, looked for air in the syringe, and tapped on the syringe to loosen and expel air bubbles. Respondent's expert witness testified that he performed an experiment creating a "wet to wet" connection with air in the MEDRAD injector syringe instead of dye. He found that the miniscus formed by blood and air in the syringe has an identical appearance to blood contacting dye in the syringe. The "wet to wet" connection between blood and air in the syringe has the same appearance as a "perfectly clean", "wet to wet" connection between blood and dye in the syringe. Respondent's expert witness testified that from five to ten percent of the time a "perfectly clean", "wet to wet" connection occurs in which no air bubbles appear between the blood and dye. Petitioner's expert witness testified that the physician must make absolutely certain that no gross amount of air is injected into the patient, and, relying on his view that the Respondent as the physician was the "captain of the ship," he testified that "the injection of this volume of air during the ventriculogram fell below the cardiology "standard of care." Petitioner's expert rendered his opinion based upon his examination of the hospital records. Respondent's expert rendered his opinion based upon his examination of the following: Administrative complaint with supporting documents. Dr. Allen Seals' (Petitioner's expert) report and deposition. Agency for Health Card Administration investigative report. ORMC's Code 15 report. Respondent's February 21, 1997 memo for peer review purposes. Hospital records. Death résumé. ORMC's MEDRAD policy/procedure. Experimentation with a catheter and MEDRAD injector. Respondent's expert testified that Respondent met the standard of care in the instant case because he practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. Based on the totality of the evidence presented, the undersigned rejects the expert opinion of Dr. Allen Seals, M.D., Petitioner's expert witness, and accepts as being more credible the testimony of David P. Browne, Jr., M.D., Respondent's expert witness.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order finding that Respondent is not guilty of violating Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint. DONE AND ENTERED this 13th day of February, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK 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 13th day of February, 2001. COPIES FURNISHED: Ephraim D. Livingston, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Robert D. Henry, Esquire Martin D. Buckley, Esquire Ringer, Henry & Buckley, P.A. Post Office Box 4922 Orlando, Florida 32801-4229 Tanya Williams, Executive Director Department of Health Board of Medicine 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703
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, a physician, violated the provisions of Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, as alleged in the administrative complaint and the penalties, if any, that should be imposed.
Findings Of Fact At all times pertinent to this proceeding, Respondent was licensed as a physician in the State of Florida and held medical license number ME00597713. Respondent graduated from medical school in the Dominican Republic in 1981. Subsequent to medical school, Respondent completed a year residency at St. Clare's Hospital and Memorial Center in New York City, which was affiliated with New York Medical College. Respondent completed a second year of surgical residency at University of Miami, Jackson Memorial Hospital. Respondent then completed one year of flexible residency and three years of internal medicine residency at Mercy Catholic Medical Center, which was affiliated with Thomas Jefferson University in Philadelphia, Pennsylvania. Respondent has practiced as an emergency medicine physician since 1988. Respondent has served as the medical director of the emergency department of Palm Springs General Hospital, Hialeah, Florida, since 1990. At the times pertinent to this proceeding, Respondent was not board certified in any specialty. The administrative complaint centers on Respondent's treatment of patient R. A., a 48 year old male, at the Palm Springs emergency room on December 24, 1991. EMERGENCY ROOM TREATMENT ON DECEMBER 23, 1991 R. A. presented to the Palm Springs emergency room on December 23, 1991, at 3:50 p.m., via ambulance. He complained of severe epigastric pain over the past 24 hours that radiated to the right quadrant of his back. His blood pressure reading was 230 over 110. R. A. reported that he smoked a pack of cigarettes a day, did not drink alcohol, and had no allergies. R. A. also reported that he had not been vomiting. On December 23, 1991, R. A. was treated by Dr. Wilfred P. Fernandez, an emergency room physician employed by Palm Springs. Dr. Fernandez took the patient's medical history and then proceeded with his physical examination. The examination of the head, ears, eyes, nose, and throat were within normal limits. The lungs were clear and the heart rate and rhythm were regular. The abdominal evaluation demonstrated positive bowel sounds and positive epigastric tenderness. There was no guarding or rebound tenderness. A rectal exam revealed there was no blood in the stool. The extremity evaluation was within normal limits, as was the neurological evaluation. Dr. Fernandez ordered several diagnostic studies, including a complete blood count, an EKG, chest x-ray, abdominal film, and gallbladder sonogram. For reasons that were not made clear, the gallbladder sonogram was not performed. All other diagnostic tests were unremarkable. At 4:45 p.m. on December 23, 1991, Dr. Fernandez prescribed the following medications for R. A.: Donnatal, Maalox, Procardia, and Reglan. Donnatal contains a mild sedative and belladonna contains alkaloids to treat spasms. Maalox is an anti-acid. Procardia contains a channel blocker and was used to treat his hypertension. Reglan was administered via IV to clear R. A.'s bowels. R. A. was discharged from the Palm Springs emergency room at approximately 6:30 p.m. on December 23, 1991. On discharge, Dr. Fernandez gave R. A. a tablet of Clondine for his hypertension and prescriptions for Clondine 1 mg. and Zantac 150 mg. Dr. Fernandez instructed R. A. not to smoke, not to drink, and not to operate dangerous machinery while on the prescribed medication. R. A. was instructed to see his personal physician or return to the emergency room if his condition worsened. R. A. did not have his prescription for Clondine or for Zantac filled before his second admission to Palm Springs emergency room on December 24, 1991. EMERGENCY ROOM TREATMENT ON DECEMBER 24, 1991 On December 24, 1991, R. A. presented to Palm Springs emergency room for the second time. R. A. was transported to the emergency room by Hialeah Fire Rescue and arrived at approximately 6:05 p.m. On arrival, R. A. complained of epigastric pain. His vital signs at 6:10 p.m. included his blood pressure reading of 230 over 130. The nurses notes for this visit reflect that the patient had been seen the day before and had received a GI (gastrointestinal) cocktail, which is a reference to the concoction given to him to relieve his epigastric pain. Respondent treated R. A. while he was at the Palm Springs emergency room on December 24, 1991.1 At 6:20 p.m., Respondent performed his initial evaluation of R. A. Respondent took a history from the patient and observed the patient's appearance and composure. R. A. reported that he had not filled his prescriptions from the prior day. He reported to Respondent that he had epigastric pain in the mid-epigastric region that had been ongoing for several days. R. A. also reported that the medications he had received the previous day had helped him. Respondent noted the initial blood pressure on admission and that the patient had not filled his prescription for Clondine. Respondent discussed with R. A. the importance of taking Clondine for his hypertension. After observing the patient initially and obtaining a history, Respondent requested the emergency room records for R. A. from the previous day. He noted that Dr. Fernandez diagnosed the patient's condition as dyspepsia and hypertension. He also noted the laboratory and radiological studies that had been ordered, including that a gallbladder ultrasound had been ordered. The records did not at that time indicate that the gallbladder ultrasound had not been performed. Respondent discussed R. A.'s prior visit with an emergency room nurse who had participated in his treatment on December 23, 1991. The nurse told Respondent that all tests were normal. Respondent understood from what the nurse had told him that the gallbladder ultrasound was also normal. It is common practice for an emergency room doctor to rely on such statements from an emergency room nurse. Respondent thereafter performed an appropriate physical examination of R. A. The patient's eyes were found to be slightly jaundiced (icteric), which was a factor in leading Respondent to suspect that the patient may have had an illness affecting his liver, such as hepatitis. The abdominal evaluation revealed epigastric tenderness on palpation but no rebound. The patient's blood pressure was elevated. All other physical findings were within normal limits. A consistent blood pressure of 230 over 130 or higher is considered hypertension that warrants treatment before discharge. Labile hypertension is the acute elevation of blood pressure caused by anxiety, stress, or pain. Labile hypertension will often resolve itself without treatment once stressors or pain is resolved. A patient with a blood pressure of 230 over 130 who is suspected of suffering labile hypertension should have his blood pressure checked no less than every fifteen minutes to observe whether the hypertension resolves itself. Based on the patient's history and his evaluation and observation of the patient, Respondent determined that R. A. was more likely suffering from labile hypertension than from an emergent condition that warranted emergency treatment of the patient's hypertension. Respondent thereafter administered to the patient what was referred to as a GI cocktail to relieve his epigastric distress. The GI cocktail consisted of Zantac, Connatal, and Viscous Lidocaine and was administered at approximately 6:30 p.m. Respondent believed it likely that the GI cocktail would reduce the patient's pain and result in a lowering of the patient's blood pressure. The emergency room staff checked R. A.'s blood pressure every fifteen minutes and advised Respondent of the readings. Respondent ordered additional tests to evaluate whether the patient's epigastric pains were symptoms of a condition that required emergency care. Respondent ordered a complete blood count, a liver profile, and EKG and an abdominal x-ray. The blood studies came back within normal limits. The liver profile indicated an elevation of serum bilirubin as well as an elevation of the liver enzymes. All other tests were within normal limits. The GI cocktail relieved most of R. A.'s epigastric pain. Because he had lingering discomfort, Respondent administered a small dose of Demerol and Vistaril, which completely relieved R. A.'s pain. Respondent determined that R. A. was not suffering from a condition that required emergency care. He formed the opinion that the patient had hepatitis, but that his condition did not require immediate hospitalization. At approximately 9:00 p.m., R. A. was discharged from the Palm Springs emergency room. At the time of his discharge, R. A.'s blood pressure was approximately 160 over 80, which is within acceptable limits. Prior to his discharge, Respondent spoke with the physician who he thought would be following R. A.'s condition. This physician had treated R. A.'s wife, but he had not treated R. A. The patient was also given the name of a doctor who was on the hospitals primary physician call list. Also prior to discharge the patient was instructed not to drink any alcohol while taking his medication, to fill his prescriptions for Zantac and Clondine, and to follow-up with his primary care physician in three to four days. He was also instructed to eat lightly and increase fluid intake. Respondent told R. A. to return to the emergency room or go to his primary physician if his condition worsened. Respondent's care and treatment of R. A., including his determination that the patient did not require further emergency treatment did not fall below the standard of care imposed on emergency room physicians. As will be discussed below, his diagnosis of hepatitis was incorrect. The testimony of Dr. Dellerson established that the incorrect diagnosis did not fall below the standard of care imposed on emergency room physicians. THE MEDICAL RECORDS FOR DECEMBER 24, 1991 R. A.'s records for the emergency room visit to Palm Springs on December 24, 1991, indicate that his blood pressure reading at 6:45 p.m. was 230 over 170. This is the last recorded blood pressure reading for R. A. on December 24, 1991. Respondent testified, credibly, that R. A.'s blood pressure was checked approximately every 15 minutes and that his blood pressure came down to an acceptable level during the course of his emergency room stay on December 24, 1991,2 but that the records do not reflect those blood pressure readings. While it was the emergency room nurse's responsibility to take and to record that blood pressure, Respondent had the ultimate responsibility for the records as the treating physician. Although Respondent's practice did not fall below the standard of care imposed on emergency room physicians, the records that were kept were inadequate to reflect the patient's condition or to justify the Respondent's course of treatment.3 EMERGENCY ROOM TREATMENT ON DECEMBER 25, 1991 On December 25, 1991, R. A. presented to Jackson Memorial Hospital at approximately 2:10 p.m. He complained of epigastric pain that radiated to his back. He had vomited earlier that morning and had noticed blood in his vomit and blood in his stool. These were complaints and symptoms that were not present the day before. At the time of his presentation, his blood pressure was 160 over 110. The following day a CT scan was performed that led to a diagnosis of gall stones in the gallbladder and in the distal common bile duct, which did not require emergency surgery. R. A. was also diagnosed as having suffered a recent hypertensive stroke. This stroke most likely occurred after the patient presented at Jackson Memorial Hospital.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order that dismisses count one of the Administrative Complaint, but finds Respondent guilty of violating Section 458.331(1)(m), Florida Statutes, as alleged in count two of the Administrative Complaint. It is further recommended that Respondent be reprimanded and assessed an administrative fine in the amount of $250.00. DONE AND ENTERED this 14th day of July, 1997, in Tallahassee, Leon County, Florida. Hearings Hearings CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative this 14th day of July, 1997
Findings Of Fact § 57.111(3)(f) Fla. Stat. (2005) "state agency" The Department of Health meets the definition found within Section 120.52(1)(b)1, Florida Statutes (2005), as an "agency." § 57.111(3)(b)2. and 3., Fla. Stat. (2005) "initiated by a state agency." On June 21, 2005, an Administrative Complaint in Department of Health, Petitioner, v. Donna M. Cameron Connolly, R.N., C.R.N.A, Respondent, DOH Case No. 2004-34970 was signed and served on Nurse Connolly. It accused the Respondent of violating Section 464.018(1)(n), Florida Statutes (2002), in the treatment and care of Patient M.M. Nurse Connolly elected to contest material facts within the Administrative Complaint. On September 9, 2005, the case was referred to the Division of Administrative Hearings (DOAH) to conduct a hearing pursuant to Section 120.57(1), Florida Statutes (2005). It became DOAH Case No. 05-3268PL. The hearing was held, and, on December 8, 2005, a Recommended Order was entered with a recommendation that the case be dismissed. § 57.111(3)(c)1., Fla. Stat. (2005) "prevailing small business party" On February 27, 2006, the Department of Health entered a Final Order dismissing the Administrative Complaint against Nurse Connolly. § 57.111(3)(d)1a., Fla. Stat. (2005) "small business party" The incident involving Patient M.M. that related to the Administrative Complaint took place on March 13, 2003. On the date Nurse Connolly cared for Patient M.M. She did so at Endosurg Outpatient Center (Endosurg) in Lady Lake, Florida, a gastroenterologist practice. She was providing anesthesia to the patient during a colonoscopy. She was acting as an independent contractor for a limited period of time in her engagement with Endosurg. It is her routine to take temporary positions in providing her services. Nurse Connolly works through placement agencies who serve clients who have the need for anesthesia coverage by a C.R.N.A. The placement agency, Nature Coast Anesthesia Providers (Nature Coast), had contacted Respondent to determine her interest in working for two weeks at Endosurg. For the services provided at Endosurg, Nurse Connolly had a verbal agreement with Nature Coast that formed the basis for her pay. The equipment and materials necessary to perform her duties at Endosurg were to be provided by that entity. In addition to the equipment provided by Endosurg, Petitioner Connolly had certain equipment of her own, including a stethoscope and an ambu-bag. At the time that the incident involving Patient M.M. occurred, Nurse Connolly had worked for Endosurg in two separate facilities for seven days. After the incident involving Patient M.M., Petitioner worked for Endosurg for an additional three days. For the year 2003, Petitioner Connolly and Joseph F. Connolly filed a Joint Form 1040 U.S. Individual Income Tax Return, with a Schedule C, representing profit or loss from a business naming Donna C. Connolly as a proprietor, "anesthesia provider," reflecting income and expenses with a net profit of $34,506.00. In 2003, Nurse Connolly's proprietorship carried business insurance through Bloom Insurance Services with a policy written by Evanston Insurance Company. Nature Coast paid Nurse Connolly for services provided at Endosurg. No insurance coverage was provided to Nurse Connolly from Nature Coast for the work done at Endosurg, nor was she entitled to any form of benefits from Nature Coast for that work. Nurse Connolly gave Nature Coast an invoice reflecting the services provided at Endosurg for which she requested payment and was paid. Nurse Connolly had other arrangements with agencies in 2003 to place her. Those agencies were Nation Wide Anesthesia Services and MDA Associates. Arrangements with the latter two agencies were under terms set forth in written contacts. At all times relevant Nurse Connolly did not advertise her services as a sole proprietor. She did provide business cards that set forth her address, telephone number, and e-mail. When performing her duties as an anesthesia provider in outlying locations, Nurse Connolly deducts meals, hotel expenses and her malpractice insurance for purposes of her income tax return. During the relevant period in time, Nurse Connolly had no other employees working for her. Her net worth was not more than two million dollars. § 57.111(4)(b)1., Fla. Stat. 2005 "itemized affidavit" To support Nurse Connolly's application for attorney's fees and costs, an affidavit has been provided by her counsel setting forth a claim for 105.1 hours of work performed by the law firm at a charge of $350.00 per hour for legal services, with an additional $45.08 in costs for federal express expenses in relation to her defense against the Administrative Complaint in DOAH Case No. 05-3268PL/DOH Case No. 2004-34970. The affidavit was prepared on May 23, 2006. Counsel for Petitioner Connolly also provided an itemized statement of work done between June 7, 2005, and February 5, 2006, as to the dates and nature of the services and time necessary to perform the incremental services totaling 105.2 hours, a discrepancy compared to the affidavit of .1 hours. In further support of the request for attorney's fees and costs, the application is accompanied by an affidavit provided by Paul C. Perkins, Jr., Esquire, as to the reasonableness of the fees requested for 105.1 hours of time expended. He comments, that recognizing the complexity and novelty of the issues in the case, an hourly rate for attorney work performed would range from $250 to $400 an hour. Attorney Perkins, like Petitioner Connolly's counsel, practices law in Florida. The affidavit by attorney Perkins refers to his admission to the Florida Bar and license to practice in the State of Florida for a period of 14 years. The affidavit was executed before a notary in Seminole County, Florida. In particular, he speaks to the complexity of the underlying case involving the administrative prosecution of Nurse Connolly, as a matter where expert testimony in the areas of pharmacology, anesthesiology, and cardio-pulmonary health were considered. In addition, the underlying case involved medical ethics and extensive research, according to attorney Perkins. On September 20, 2006, Nurse Connolly's attorney in this case, Damon A. Chase, Esquire, filed a supplemental affidavit as to attorney's fees and costs in the matter, asking that he be reimbursed for his fees at a rate of $350.00 per hour. Attached to the affidavit was a rendition of the services provided in the present case from July 12, 2006, through September 5, 2006, totaling 24.4 hours. A second affidavit by attorney Perkins has not been filed to support the additional 24.4 hours. § 57.111(4)(c), Fla. Stat. (2005) "opposition affidavit" Respondent in this cause filed a counter-affidavit in opposition to Petitioner's attorney's affidavit for fees and costs. The counter-affidavit was provided by Edwin A. Bayo, Esquire, who practices in Leon County, Florida, where he has practiced for the last 22 years. The majority of his practice was in the Office of the Attorney General, State of Florida. Attorney Bayo served as Board counsel for professional regulatory boards to include the Boards of Pharmacy, Dentistry, Osteopathic medicine, Chiropractic medicine, Veterinary medicine and Professional Engineers. His law practice has involved significant administrative law litigation. In response to the original request for reimbursement of attorney's fees in relation to the 105.1 hours, his opinion is that the appropriate hourly rate for the type of work performed in the case, as reviewed by Attorney Bayo, would be from $200 to $325 an hour, with the higher rate of charge being associated with counsel who has had more experience in administrative litigation, that is to say in excess of 15 years. Attorney Bayo contrasts that number of years with the amount of time that counsel for Nurse Connolly has been in practice in Florida, which attorney Bayo represents as being three years. Ultimately attorney Bayo offers the opinion that the rate of reimbursement for Attorney Chase should not exceed $225 per hour. § 57.111(4)(d)1., Fla. Stat. (2005) "nominal party" When the Department of Health undertook its prosecution directed to Donna M. Cameron Connolly, R.N., C.R.N.A., it was not acting as a nominal party. § 57.11(3)(e), Fla. Stat. (2005) "substantially justified" Exhibit "B" to Respondent's Notice of Filing of Additional Documents in the present case, as filed August 25, 2006, is constituted of the investigative report by the Department of Health, with exhibits. It includes patient records and expert opinions in DOH Case No. 2004-34970, all the material being mailed to the Probable Cause Panel which decided in favor of Probable Cause to bring the Administrative Complaint in the case. Exhibit "B" also contains the written response to the investigation provided by Nurse Connolly. The information available to the Probable Cause Panel continues in this discussion. On April 8, 2003, a confidential code 15 report was received by the Health Facility Regulation Hospital and Outpatient Services, within the State of Florida, Agency for Health Care Administration. In content, it pertained to Patient M.M. The report was made in compliance with Section 395.0197(8), Florida Statutes (2002). The report concerned the incident on March 13, 2003, which forms the basis of the administrative prosecution that underlies the present case. The Code 15 report was acknowledged by an Investigation Specialist with the Department of Health in a letter to the reporter dated July 1, 2003. Beyond that date, the Department of Health undertook its investigation into the matter concerning Patient M.M. and her treatment on March 13, 2003. After the investigation commenced, a Uniform Complaint Form was executed by the Investigation Specialist for the Department of Health, in a setting were Donna Connolly was named as the Respondent in relation to the March 13, 2003, incident. Generally, it summarized the events of that day and the withdrawal of life support from Patient M.M. on March 16, 2003, followed by the patient's death on March 17, 2003. The focus of the investigation was on a possible violation of Section 464.018(1)(h), Florida Statutes (2002), and Florida Administrative Code Rule 64B9-8.005(2)(i). In pursuing the investigation, the Department of Health made contact through its investigator with an official at Endosurg in Lady Lake, Florida. The investigation was facilitated by a subpoena issued October 8, 2003, calling for the release from Endosurg of medical information about Patient M.M. and the care received at Endosurg. The subpoena duces tecum that was sent to Endosurg on October 8, 2003, asked for the outpatient center to provide a copy of the medical records for the March 13, 2003, admission in relation to Patient M.M. Among the items that Endosurg gave the Department of Health concerning the care received by Patient M.M. on March 13, 2003, were the nursing assessments, pre-op and post-op information, the endoscopy report for the procedure being performed on the patient, the anesthesia record, the endoscopy procedure record, the past medical history of the patient, information concerning the provision of anesthesia in advance of its provision, a pre-operative evaluation questionnaire including the history of present illnesses, physical examination and a cardio-pulmonary resuscitation report form in relation to the CPR team who responded to the patient's arrest, which the report form refers to as occurring around 7:45 a.m. on March 13, 2003. It describes the CPR team responding to the incident as Nurse Connolly; Nurse Mayhew, who was a registered nurse; and the attending physician, who performed the colonoscopy. The Department of Health also issued a subpoena duces tecum to Lake Sumter Emergency Medical Services of Mt. Dora, Florida, who responded to the incident, providing care and transport for Patient M.M. on March 13, 2003. In response the Medical Services Agency provided transport information in relation to Patient M.M., who had suffered the cardiac arrest and was taken to the Villages Regional Hospital (Villages Hospital). A copy of a report reflecting the intubation and treatment provided by the agency to the patient was also given to the Department of Health, with a code summary critical event record. The patient was taken to the Villages Hospital for emergency treatment. The Department of Health issued a subpoena duces tecum to the hospital. The response to the subpoena included a written record of the diagnosis, including cardiac arrest, anoxic brain damage. Information from the Villages Hospital included physicians' orders, history and physical, laboratory studies, diagnostic studies, etc. The clinical indication at the time the patient was cared for in the Villages Regional Hospital was that the status was post-cardiac arrest, altered mental status. On that same date, March 13, 2003, the patient was transferred from the Villages Hospital to Lake Regional Medical Center (LRMC) in Leesburg, Florida. LRMC also provided records related to Patient M.M. The information received from LRMC was pursuant to a subpoena duces tecum. The death summary provided by LRMC, where Patient M.M. expired on March 17, 2003, referred to a discharge diagnosis as, severe anoxic encephalopathy following cardio- respiratory seizure, and cardiac arrest secondary to ventricular fibrillation. The patient expired when life support was withdrawn. LRMC patient information included physician's orders, patient progress notes, medication administration record, etc. On March 21, 2003, an associate medical examiner for the District Five Medical Examiner's office located in Leesburg, Florida, determined that the cause of Patient M.M.'s death was hypertensive and arteriosclerotic heart disease. On October 20, 2004, a medical malpractice investigator for the Department of Health wrote to Donna Connolly, A.R.N.P., advising her of Complaint No. 2004-3490. That correspondence referred to an enclosed document that had been determined sufficient for investigation pursuant to Section 456.073, Florida Statutes (2004), and extended an invitation to Nurse Connolly to file a written response or to call in and schedule an interview within 20 days of receiving the letter. Nurse Connolly was reminded that any response "will be made a part of the file and will be considered by the Department and the Probable Cause Panel in determining whether a formal Administrative Complaint should be filed in the matter." Nurse Connolly was also advised that she was not required to answer any questions or give statements and that she could be represented by counsel. On November 12, 2004, as received by the Department of Health on November 15, 2004, Nurse Connolly responded in writing to the ongoing investigation addressing the documents involved in the investigation. She provided an explanation of her recollection of the events on March 13, 2003, related to the care she provided Patient M.M., disavowing any unprofessional conduct on her part. On June 1, 2005, an Order of Emergency Restriction of the license of Donna M. Cameron Connolly, A.R.N.P., C.R.N.A, was entered by the Secretary of the Department of Health. The significance here, is that C. Erwin Velbis, C.R.N.A., A.R.N.P., performed a review of what was referred to at that time as Case No. 2004-3490. On February 4, 2005, utilizing an outline provided by the Department of Health, he performed the medical review related to the overview of the March 13, 2003, case involving Patient M.M., the colonoscopy and the eventual death of the patient on March 17, 2003. In response to the question in the form, Question 3, which says: The applicable standard of care, step by step in this case is He replied: Preanesthesia Care, Basic Standards for Basic Anesthetic Monitoring, Standards for Safe use of Propofol Appropriate level of sedation (Monitored Anesthesia Care vs. Conscious Sedation vs. Deep Sedation/Analgesia vs. General Anesthesia Postanesthesia Care, Basic Standards for Documentation of Anesthesia Care Nurse Velbis indicated that Nurse Connolly, in providing care to Patient M.M. on March 13, 2003, failed to meet the standard of care set out in the questionnaire by: Subject's PACU arrival vital signs do not reflect what was first documented by nursing staff which revealed hypotension and bradycardia that was treated with romazicon and trendelenburg positioning. Subject left an unstable patient upon arrival to PACU no documented ECG rhythm strips support what dysrhythmia patient was having that required ACLS. Under the response to question number 6 in the form, Nurse Velbis opines that Nurse Connolly should have done the following: Stayed with patient upon arrival in the PACU after a bp 74/42 and p40 was assessed Initiated defibrillation more quickly once the airway was secured (10 minutes had expired before the Fire and Rescue Paramedics defibrillated the patient). Provided clear ECG documentation. In this review, Nurse Velbis indicated items that might increase or lessen Nurse Connolly's culpability to the effect: gastroenterologist assumed "captain of the ship" regarding responsibility and accountability in the anesthesia care team model no supplemental oxygen was applied to the patient at PACU nor were [sic] there documentation of the SpO2 dose of Romazicon given by PACU nursing staff is unknown from the records. Was the dosage appropriate for the level of sedation? Nursing staff should have called the subject if Ramazicon was necessary to awaken a previously conversant patient What is the patient to staff ratio in the combined holding area in PACU? Depositions illustrate providers physically too far away from the patient in this case (this is an obese patient with a BMI of 35, no supplemental oxygen, and in trendelenburg position). Patients can resedate and become apneic without continual stimulation. Nurse Velbis was also asked to comment on the Emergency Restriction Order in draft form, which took into account his expert opinion that had been rendered in his written review as a means to make certain that the Emergency Restriction Order accurately reflected his expert opinion. There was also a reference in April 4, 2005, correspondence to Nurse Velbis concerning the addition of a paragraph 19 to the Emergency Restriction Order describing Nurse Connolly's failure to utilize the bag-valve mask immediately as a failure to meet applicable standards of care. This correspondence also describes some discrepancy between the author and Nurse Velbis concerning information that he had reflected in his written review about vital signs associated with Patient M.M. when the patient first arrived at the PACU at Endosurg. On April 21, 2005, Nurse Velbis responded in writing to the April 4, 2005, correspondence, giving advice to omit paragraph 19c to the Emergency Restriction Order for reasons stated in the written response noting in the end that Nurse Connolly "remains justfully [sic] culpable for the underlying cause, primarily hypoxia, of M.M.'s PEA rhythm." Nurse Velbis, who had been called upon to review materials associated with the investigation into Nurse Connolly's conduct on March 13, 2003, in treating Patient M.M., had access to the Department of Health's investigative report that included medical records. Nurse Velbis' assessment of the circumstances in relation to care of Patient M.M. received on March 13, 2003, at Endosurg, contrasts with the January 11, 2005, memorandum from Kay Frank, R.N., B.S.N., a nurse consultant whose recommendation was "close complaint against D.C. (Donna Connolly) no violation. Consider further investigation of recovery and resuscitation of this client." The investigative report form by the Department of Health that addressed the complaint that was made October 15, 2004, was completed when approved on December 30, 2004. By its table of contents, it refers to written records received from the various sources under subpoena duces tecum to Endosurg, Lake Sumter Emergency Medical Services, Villages Hospital, and LRMC, with a summary of the impression gained from a review of these materials. The investigative report also includes summaries of interviews conducted with the Endosurg Risk Manager Consultant; the Nurse Administrator at Endosurg; the Risk Manager of the Villages Hospital; Maureen Mayhew, R.N. at Endosurg, who was in the PACU when Patient M.M. was transferred to that unit from the procedure room; and the Risk Manager for LRMC, as well as a summary of Nurse Connolly's response to the investigation. On June 20, 2005, a Probable Cause meeting was convened in which panel members Maria Seitz and Jeanne Stark participated. As the transcript of that meeting establishes, the panel members confirmed that they had had sufficient time to review the materials that have been described in aid of their deliberations. Among the cases on the agenda was the subject case involving Donna Connelly. Attorney Judy Law from the Department of Health, who participated in the panel discussion, noted that the panel members had been provided with complete case files including the investigative reports, attached exhibits, all patient medical records, and any expert opinion, as well as any material provided by a licensee to respond to the Department investigation. It was indicated that the panel members had been provided a draft of the Recommended Administrative Complaint in the Connolly case. Attorney LeeAnn Gustafson for the Board of Nursing, who participated in the meeting for probable cause, explained to the Probable Cause Panel members, that if they had questions concerning interpretation or the application of any provision within Chapters 456 and 464, Florida Statutes, they should direct them to her, as well as any of the specifics concerning the cases that were on the agenda at that time, to include the case involving Nurse Connolly. There is a reference in the probable cause transcript to a scrivener's error that needed clarification in the Administrative Complaint related to Nurse Connolly and a need to correct numbers in the paragraphs to the Administrative Complaint without changing the underlying facts. The panel members agreed to these corrections. During the Probable Cause Panel meeting, a Mr. Monte gave a case overview involving the March 13, 2003, incident related to Patient M.M. and commented that the basis for the case was a failure to meet minimum standards of acceptable and prevailing nursing practice: by leaving an unstable patient; by failing to verify the patient's vital signs upon admission; by failing to stay with the patient long enough to ensure that the patient was stable; by disregarding the patient's unstable vital signs; by failing to provide oxygen via bag, valve or mask, or through incubation (intubation) immediately; by failing to ensure the proper equipment for incubation (intubation) was readily available; by failing to utilize incubation (intubation) equipment in a timely fashion, as necessary to restore breathing in an emergency; and by choosing to use mouth to mouth resuscitation as a first intervention. With this explanation, Ms. Sietz moved to find probable cause, which was seconded by Ms. Starke. There ensued subsequent discussion about the case between the panel members and a possible disposition of the case by way of discipline imposed on Nurse Connolly. § 57.111(4)(a), Fla. Stat. (2005) "special circumstances" No evidence was presented by Respondent in this case to show that special circumstances exist which would make the award of attorney's fees and costs unjust.
Conclusions THE PARTIES resolved all disputed issues and executed a Stipulation and Agreement. The parties are directed to comply with the terms of the attached stipulation and agreement. Based on the foregoing, this file is CLOSED. DONE and ORDERED on this the 1i f- day of CJcfi>bA,y- , 2009, in Tallahassee, Florida. Filed October 12, 2009 11:38 AM Division of Administrative Hearings. DOAH Cases No. 09-0355MPI and 09-0359RU AHCA v. HEARTLAND and HEARTLAND v. AHCA Final Order w-JL H?LLY BENSON, sbARY Agency for Health Care Administration A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO A 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 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. Copies furnished to: Debora E. Fridie, Esq. Agency for Health Care Administration (Interoffice Mail) William M. Furlow, III, Esquire Metzger, Grossman, Furlow & Bayo, LLC 1408 North Piedmont Way Tallahassee, Florida 32308 (U.S. Mail) The Honorable Daniel Manry Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (U.S. Mail) Kenneth Yon, Bureau Chief, MPI Agency for Health Care Administration (Interoffice Mail) Peter H. Williams, Inspector General Agency for Health Care Administration (Interoffice Mail) Finance and Accounting Agency for Health Care Administration Page 2 of3 DOAH Cases No. 09-0355MPI and 09-0359RU AHCA v. HEARTLAND and HEARTLAND v. AHCA Final Order CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished to the above named addressees by U.S. Mail and/or Interoffice Mail on this the / y of Richard Shoop, Esquire Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308-5403 Page 3 of3 7 /i 7 /2009 1::.a PH Fl\OM: 863-J8f,-8t44 Heartland Int •·n;,l Med TO: 1- ;.o-:,ss-1953 PAGE: 002 OF 011 STATE OF FLORIDA DIVISION PF ADMfN!STRATIVE 1-mARfNGS
The Issue Whether Respondent, Dien Duong, violated the provisions of Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, as specifically alleged in the Administrative Complaint, and, if so, what penalty would be appropriate.
Findings Of Fact Based upon observation of the witnesses and their demeanor while testifying, the documentary evidence received, and the entire record compiled herein, the following material and relevant facts are found: Petitioner, Department of Health, Board of Medicine, is the state agency charged with regulating the practice of physician's assistants pursuant to Chapters 455 and 458, Florida Statutes, and Section 20.43, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician's assistant in the state of Florida, having been issued license number PA 0003211 in 1997. Respondent received a Bachelor's Degree in Biology from Hope College, Holland, Michigan, in 1989 and thereafter received her physician's assistant degree from Western Michigan University in 1991, and became certified in Family Practice and in Surgery in Michigan upon graduation. Respondent has maintained her certification in Family Practice and in Surgery by successfully passing an examination every six years since 1991, in addition to taking a minimum of 100 hours of Continuing Medical Education (CME) courses each year. In 1997 Respondent began working at South Florida Baptist Hospital Emergency Department and has maintained her employment in that department as a physician's assistant. During the course of her employment, Respondent has gained extensive experience in the practice of assessing lacerations and repairing lacerations of all types. Respondent is highly respected by her employing physician, Dr. Charles Eaves, and by her supervising physicians in the emergency department of the hospital. Respondent has never been the subject of discipline or corrective action regarding her professional job performance as a physician's assistant. A physician's assistant is a licensed health care professional who works under the supervision of a doctor. Typical protocol between the supervising doctor and the physician's assistant is for the physician's assistant to inspect and evaluate the patient, examine the injury, prepare the patient for treatment, consult with the supervising doctor, and thereafter administer treatment to the injury approved by the doctor, followed by after-care instructions to the patient. Based upon the testimony of the experts, the protocol between experienced physician's assistants and their supervising doctors is based upon the doctor's respect and confidence in the physician's assistant's abilities, competence, experience and work history. In these mutual trust and respect working relationships, protocol typically permits the physician's assistant to work relatively autonomously. Without involvement of the supervising doctor, the physician's assistant examines emergency room injuries; they often treat the injured patient, and thereafter present the patient's case treatment and the patient's medical record to the supervising doctor for approval and, when recommended, signature for prescribed medication. The protocol between Respondent and her supervising physician, Dr. Diaz, at South Florida Baptist Hospital on May 8, 1998, was that of mutual trust. Patient D.Z. was a 33 year-old male who had fallen from a ladder and, while attempting to break his fall with his right hand, suffered a blunt, T-shaped, tear-like laceration injury to his right hand. The injury was on the palmar aspect in the area of the fifth metacarpal of the hand-bone that extended to the small finger; a complex laceration, described by doctors as a "sort of bust or blunt type," as opposed to a clean knife cut type, approximately 3/4 centimeter in depth. On May 8, 1998, D.Z. presented himself to the South Florida Baptist Hospital (Hospital) emergency room for treatment of his right hand laceration that extended to the subcutaneous level with subcutaneous tissue exposure. The Hospital's triage nurse, after completing preliminary patient information, directed D.Z. to First Care, that part of the hospital's emergency department where Respondent was working. Respondent, following protocol, examined D.Z.'s injured right hand and ordered x-rays to be taken. An x-ray was taken of D.Z.'s right hand and was reviewed by Respondent's supervising physician, Dr. Diaz, prior to treatment of the injury by Respondent. Dr. Diaz concluded that D.Z.'s x-ray was negative, with no broken bones or tendon involved. The medical records noted that D.Z. had the full range of motion of his fingers without numbness or tingling at that time. Respondent's treatment of D.Z. consisted of laying D.Z. on his back with his arm out to his side and using local anesthesia to numb the injured area. After numbing the hand, she infiltrated the wound with one percent plain Lidocaine, irrigated the wound with normal saline, and cleaned the wound with Betadine. She then debrided the tissue. Using sterile techniques, Respondent proceeded to suture the T-shaped laceration of D.Z.'s right hand. Because of the shape and depth of the laceration and because of the exposure of jagged-edge tears to the subcutaneous tissues, Respondent placed four subcutaneous sutures with 4.0 vicryl, an absorbable suture, in order to bring and keep the jagged-edged tears of D.Z.'s laceration together. For the type of wound suffered by D.Z., described as "bust-type-ripping-flesh tear," it is not possible to close a three or four centimeter wound with only surface sutures. Subcutaneous sutures are required for those wounds of this type and depth. For these reasons and acting appropriately within the scope of the practice of an experienced physician's assistant, Respondent determined to use subcutaneous sutures on D.Z., who is right-hand dominate. The experts who testified, Dr. Eaves, Dr. Solomon, Dr. Maddalon and Ms. Vergara, agreed that the process of using subcutaneous sutures helps to control bleeding, reduce tension within the laceration, and minimize potential "air pockets" within the wound, thereby promoting the healing process, and preventing potential, after-surgery, complications. In accord with protocol established between Dr. Diaz and Respondent, it was at the conclusion of her treatment care of D.Z. that she advised Dr. Diaz of her subcutaneous suture treatment and follow-up care plan. Respondent presented D.Z.'s record for his review, approval and signature. Dr. Diaz approved Respondent's subcutaneous suture treatment, her follow- up care plan of keeping the wound clean, taking the prescribed medication and having the sutures removed within a few days during his follow up a doctor of his choice. Dr. Diaz signed both the Emergency Room report and Respondent's suggested prescription medications for D.Z. On May 11, 1998, four days after his treatment and without obtaining and taking his prescription medications as instructed, D.Z. presented himself to Dr. Maddalon's office for a follow-up examination and evaluation of his injury. On May 14, 1998, Dr. Maddalon, who employed D.Z.'s mother as his office manager and had employed D.Z. for six years to clean his office and who had operated and treated D.Z.'s right hand for carpal tunnel syndrome some years earlier, examined D.Z.'s right hand following an earlier examination by his physician's assistant. On May 15, 1998, during exploratory surgery, Dr. Maddalon reopened the laceration of D.Z.'s right hand and observed that a subcutaneous suture had passed through the ulnar nerve and tied the ulnar digital nerve to the adjoining soft tissue. He removed the subcutaneous suture and removed the damaged part of the ulnar nerve. He then re-attached the exposed ends of the ulnar nerve. D.Z. recovered satisfactorily from Dr. Maddalon's surgery with most but not all of the sensation returning to the little finger on his right hand. According to his deposition, and without a review of D.Z.'s medical records from South Florida Baptist Hospital emergency room prepared by Respondent, Dr. Maddalon opined that certain protocol should be followed in treating "blunt-tear" type hand injuries like that suffered by D.Z. Dr. Maddalon went on to stress, however, that in his opinion placing subcutaneous sutures in such an injury as D.Z.'s was not below the standard of care for a physician's assistant. Deborah Vergara, a physician's assistant at Town and Country Hospital, Tampa, Florida, qualified as an expert in physician's assistants' duties, responsibilities and protocol, and after reviewing D.Z.'s medical records, opined that the care provided D.Z. by Respondent during treatment on May 8, 1998, was appropriate for a patient with D.Z.'s type laceration and was not below the standard of care for a physician's assistant. Deborah Vergara further opined that a suture passing through the ulnar nerve, in and of itself, is not a breach of the standard of care, and she was not aware of any textbooks for physician's assistants that prohibited ever placing subcutaneous sutures in a laceration. Dr. Charles Eaves, D.O., an expert in emergency medicine and an expert in supervising physician's assistants and who also has been the supervising doctor of South Florida Baptist Hospital for the past three years, opined that Respondent's placing subcutaneous sutures in a palmar laceration was absolutely within the standard of care. Dr. Eaves further opined that Respondent's entries in D.Z.'s medical records were within the standard of care. Dr. Barry Solomon, Board Certified expert and employed by the Physician Health Care Alliance in Clearwater, Florida, after review of all of D.Z.'s medical records from South Florida Baptist Hospital, the Administrative Compliant filed in this case, Dr. Maddalon's deposition, and records from Brandon Regional Medical Center, gave his opinions in the following areas: Protocol of supervising physician and physician's assistants working in specific areas of medicine. According to Dr. Solomon, physician's assistants generally operate with relative autonomy, based upon the experience of the assistant and the confidence of the supervising physician. Physician's assistants see low acuity patients, leaving the physician to see high acuity patients. Physician's assistants do check with the physician on duty as they proceed through treating a patient, checking to make sure what they are going to do is appropriate and have the physician review and sign the chart as the patient is being made ready for discharge. Protocol for physician's assistants suturing palmar lacerations. Dr. Solomon opined that Respondent's conduct when presented with a patient with a palmar laceration in a subcutaneous area with an abnormal, complex laceration, and after assessment for nerve damage, tendon damage, bone injury, and after obtaining an x-ray which was reviewed by the emergency room physician at the time, and then proceeding to place a two- layer closure consisting of four subcutaneous sutures and eleven external sutures to close the wound, was within the standard of care of physician's assistant, in this case, the Respondent. Dr. Solomon further opined that there is nothing wrong with placing subcutaneous sutures in a hand laceration and there is always a risk, with a deep wound that nerves, blood vessels, arteries and veins could potentially be hit or sutured. This risk is a recognized complication when one places subcutaneous sutures in that (hand) part of the body. He concludes that Respondent practiced within the physician assistant's standard of care in her subcutaneous suture treatment of Patient D.Z.'s right hand. Petitioner has failed to provide the opinion of an expert that establishes a standard of care for an experienced physician's assistant; has failed to provide evidence of standard of care for maintaining medical records; and has failed to provide an expert opinion in support of the allegation that Respondent's treatment of D.Z.'s right hand laceration fell below a physician's assistant standard of care for treatment of hand lacerations. The testimony of Dr. Charles Eaves, Dr. Barry Solomon and Deborah Vergara is credible in establishing that Respondent, Dien Duong, actions were not violations of Subsection 548.331(1)(m) and 488.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty of violating Subsections 458.331(1)(m) and (t), Florida Statutes. DONE AND ENTERED this 2nd day of May, 2002, in Tallahassee, Leon County, Florida. FRED L. BUCKINE 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 2nd day of May, 2002.
The Issue The central issue in this case is whether the Respondent is guilty of the violations alleged in the administrative complaint; and, if so, what penalty should be imposed.
Findings Of Fact Based upon the testimony of the witnesses and the documentary evidence received at the hearing, I make the following findings of fact: The Department is the state agency charged with the responsibility of regulating the profession of nursing pursuant to Chapters 455 and 464, Florida Statutes. At all times material to this case, Respondent has been licensed by the Department, license nos. RN 1672492 and 167249A. Respondent holds dual licensure since he is listed as a registered nurse (RN) and an advanced practice RN with specialty (ARNP). In Respondent's case, the advanced specialty practice is in the area of anesthesia. To become licensed as an ARNP, Respondent submitted an application, a fee, and copies of a certification from the Council on Recertification of Nurse Anesthetists (CRNA) which included an identification card specifying Respondent's CRNA number to be 24936. Respondent represented, under oath, that the copies were true and correct duplicates of the originals. Based upon this documentation, the Department issued the ARNP license. On or about March 25, 1986, Respondent was employed by the Hialeah Anesthesia Group (HAG). Respondent's supervisor was Manuel B. Torres, M. D., president of HAG. On or about November 30, 1987, Dr. Torres notified Respondent that his employment and privileges at Hialeah Hospital were being suspended. According to Dr. Torres, this suspension was to continue until confirmation was given by the Impaired Nurse Program at South Miami Hospital that Respondent's problem had been corrected. At the same time, Dr. Torres notified the CRNA that Respondent had voluntarily entered an impaired nurse program. Subsequently, Dr. Torres received a letter from Susan Caulk, staff secretary for CRNA, which notified him that, according to CRNA files, Respondent had not passed the certification examination, was not a member of the American Association of Nurse Anesthetists, and that Respondent's CRNA recertification number was not valid. Dr. Torres then notified the Department regarding the certification issue. Later, after Respondent had completed a controlled substance addiction program at Mount Sinai Medical Center, Dr. Torres advised him that, if he could prove his CRNA certification, he could be rehired at Hialeah Hospital. Respondent never returned to demonstrate his certification. An individual who represents himself to be certified as an ARNP when he has not qualified to be so certified has exhibited conduct which falls below the standard of care of the nursing practice. Further, such an individual, by practicing as an advanced practitioner without the educational background, compromises the safety of patient care.
