Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Nursing. The Petitioner regulates the practice of nursing pursuant to section 20.30, and Chapters 455 and 464, Florida Statutes. The Respondent, McDonald Knights, is a registered nurse and holder, at all times pertinent to these proceedings, of license number 1715572. He received his formal training in England and became licensed in the State of Florida by endorsement on or about May 5, 1986. At all times material to these proceedings, the Respondent was employed as a registered nurse assigned to work in the surgical cardiac care unit at Cedars of Lebanon Medical Center in Miami, Florida. Francesco Garofalo was a patient in the coronary care unit of the medical center on March 8, 1987, awaiting cardiac aortic bypass surgery the next morning as a result of acute myocardia infarction. He was being intravenously infused with two medications, lidocaine (for arrhythmia) and nitroglycerin (for pain). The medications were applied through continuous intravenous infusion at separate injection sites and through separate volumetric pumps. At approximately 7:45 p.m., the alarm sounded on the volumetric pump responsible for discharging the nitroglycerin intravenous infusion. The Respondent answered the alarm and noted the container of nitroglycerin was empty. Since the previous shift had not provided a back up container of the medication, it was necessary for Respondent to order a replacement be delivered from the unit's pharmaceutical supply. While awaiting delivery of the medication, the Respondent started a dextrose solution running into the patient to prevent the injection site from closing. At this time, the patient complained of pain at the site of his other intravenous injection for lidocaine. The Respondent determined that this injection site had been infiltrated with the lidocaine solution leaking into the subcutaneous tissue of the patient's arm, resulting in discomfort to the patient. The Respondent decided a new site should be secured. In the process of securing a new site for the lidocaine infusion, the Respondent removed a manual plunger apparatus termed a "cassette" from the volumetric pump. This action effectively discontinued the function of the pump. After inserting the needle in the new venous site, Respondent manually operated the plunger apparatus to insure that the line was open and effectively discharging a smooth flow of lidocaine medication into the patient's body. He did not establish a rate of flow for the medication into the patient's body beyond cutting down the manual flow to an amount equal, in his opinion, to 10 to 20 drops per minute. At this point, the Respondent went to take a telephone call and left the patient's care to another nurse who had entered the room. The time was approximately 7:47 p.m. Cordette Steer is a registered nurse with twenty years experience. When she entered the patient's room to allow the Respondent to take the telephone call, she received no instruction from the Respondent. She did not know the medication being injected was lidocaine. Due to the toxic nature of lidocaine and her observation that the volumetric pump for administering this medication had been effectively bypassed, Steer assumed the Respondent had hung a harmless saline or dextrose solution to keep the vein open for the injection. She proceeded to apply tape to secure the needle at the injection site because, as she testified, "nobody would expect lidocaine to be infusing off of the pump, this is something that is never done." At 7:50 p.m., the patient complained of chest pain. Steer was aware of the exhaustion of the patient's nitroglycerin and that a new bag had not yet arrived from the pharmacy. She stepped from the room and returned almost immediately with nitroglycerin tablets which she gave to the patient to relieve his chest pain. He shortly began to exhibit seizure symptoms commonly associated with lidocaine toxicity. Code Blue was sounded. The Respondent was among those personnel responding. He disconnected the lidocaine infusion, stopping the flow of lidocaine to the patient. The time was 7:55 p.m. Resuscitation attempts failed and the patient subsequently expired at approximately 8:30 p.m. Nancy Cox is a critical care educator employed with the Miami Children's Hospital. She is an expert in the fields of surgical and cardiac critical care. She reviewed the medical records pertinent to this proceeding and her expert testimony establishes that: Lidocaine is an extremely toxic medication which can be fatal if the volume administered to a patient is not closely controlled. The dosage the patient should have been receiving was 15 cubic centimeters per hour or approximately three teaspoons per hour. The volumetric pump sets the rate of delivery of an intravenous drug with a finite, or high, decree of accuracy. When the pump is turned off, with the cassette in place, the flow of medication is stopped. When the cassette is removed from the pump device, an open flow is established and the pump fails to act as a regulator. Finite control of drug administration is not possible manually, as was attempted by the Respondent in this case, without taking considerable time to adjust the rate of flow in concert with timed intervals. Even when this is done, the plunger may spring open and allow a greater than desired drug flow. The Respondent should not have established a smooth flow of lidocaine, but rather a dripping or slow rate of infusion. The Respondent deviated from accepted minimal standards of cardiac or critical care nursing when he used the lidocaine solution to initially infuse at an open, unregulated rate in order to determine if the new injection site was functioning as opposed to establishing a patent intravenous route by either injecting saline via a syringe into the catheter, or connecting a bag of a saline or dextrose solution to the catheter for this purpose and then allowing it to infuse, prior to re-connecting the lidocaine. The Respondent also deviated from accepted minimal standards of acceptable and prevailing nursing practice by not informing Cordette Steer that lidocaine was being administered intravenously to the patient without the use of the volumetric pump.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Nursing enter a final order finding the Respondent guilty of the offense charged in the administrative complaint, suspending his license for a minimum period of one year with probationary reinstatement thereafter conditioned upon 1) a showing by the Respondent that he has enrolled and completed continuing education courses, as deemed appropriate by the Board, in the area of cardiac critical care with an emphasis on intravenous medication applications, and 2) he agrees to comply with reasonable terms and conditions of the Board for a subsequent probationary period of two years. DONE AND RECOMMENDED this 22nd day of April, 1988, in Tallahassee, Leon County, Florida. DON W. DAVIS 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 22nd day of April, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-5633 The following constitutes my specific rulings, in accordance with requirements of section 120.59 Florida Statutes, on proposed findings of fact submitted by the parties. PETITIONER'S PROPOSED FINDINGS Included in finding number 2. Included in finding number 2 Rejected as unnecessary. Including in finding number 2. Included in finding number 3. Included in finding number 4. Rejected as unnecessary. Included in finding number 4. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 4. Included in finding number 4. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 6. Included in finding number 6. Included in finding number 5. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Patient was pronounced officially dead at 8:52 p.m., but Respondent testified that death occurred earlier. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected, not supported by the evidence. Included in finding number 7. Rejected as unnecessary. Included in finding number 7. Included in finding number 6. Rejected as a conclusion of law. COPIES FURNISHED: Lisa M. Bassett, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William E. Hoey, Esquire 2398 South Dixie Highway Miami, Florida 33133-2399 William O'Neill, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Judie Ritter Executive Director Department of Professional Regulation Room 504, East Coastline Drive Jacksonville, Florida 32201
The Issue The issue is whether Respondent's treatment of a patient diagnosed with a fecal impaction deviated from the applicable standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 0016053. He has been in practice for 33 years. He is Board Certified in Family Practice. Late in the afternoon of July 6, 1997, M. D., a 58- year-old female, presented to the emergency room at North Shore Medical Center in Miami, complaining of lower and upper abdominal pain, vomiting, and constipation. She reported taking a Fleets enema, but to no effect. She had been experiencing this discomfort for two or three days. Emergency room staff conducted a physical examination of M. D. and ordered blood work and abdominal x-rays. The results of the physical examination and blood work were generally within normal limits, except for generalized abdominal tenderness. M. D. also had an elevated respiration rate and a subtly elevated component of the white blood cell count. The abdominal x-rays revealed what was likely to be a fecal cast in the sigmoid colon, and the radiologist noted the possibility of a partial occlusion in the distal colon. Emergency room staff contacted Respondent for the first time at 10:30 p.m. on July 6. During the conversation, Respondent learned of M. D.'s presence in the hospital emergency room. He learned about her general history and that the results of her physical examination and blood work were generally normal, except for diffuse abdominal tenderness. He also learned generally of the results of the abdominal x-rays. Although the radiologist's report was not available, Respondent understood that the report was consistent with her complaints of constipation. A member of the emergency room staff informed Respondent of the diagnosis of fecal impaction. The staff person reported that they had found no evidence of any other acute processes and asked if Respondent wanted to admit M. D. to the hospital so that they could clear out her impaction. Respondent ordered that the hospital admit M. D. He ordered a liquid diet to rehydrate M. D. and her stool, routine monitoring of M. D.'s vital signs, bathroom privileges, Tylenol as needed for pain, a barium enema, and a standard preparation for a barium enema. The barium enema requires a clear colon. Otherwise, fecal material would show as lumps, which would be indistinguishable from colon masses. The standard preparation for a barium enema takes place over one to two days prior to the administration of the enema. Over this period of time, the patient follows a liquid diet to reduce the amount of fecal material, then takes a laxative, and finally one or more tap water, Fleets, or soap-suds enemas to clear fecal material from the lower bowel. Given the time constraints present in this case, largely due to M. D.'s discomfort, Respondent ordered a barium enema the next morning. He did not want M. D. to receive a laxative, due to the possibility of a bowel obstruction, so he ordered tap water enemas until clear. After giving the orders, Respondent planned to see M. D. at 8 a.m. the next day. Unknown to Respondent, the standard practice at the hospital was to prepare the patient for the barium enema with a laxative, even if the physician ordering the enema did not expressly request one and did expressly request a tap water enema. At 12:30 a.m. on July 7, a hospital nurse administered a saline laxative in the form of a Fleets Phospho-Soda. This gentle laxative is an osmotic agent that draws fluid into the bowel, although it also generates some gastrointestinal peristalsis, by which muscular bowel contractions propel the bowel's contents from the upper portion of the intestinal tract to the rectum. Hospital staff administered a tap water enema to M. D. at 4:00 a.m. on July 7. She did not tolerate the enema well and began to complain of stomach cramps. The record is not entirely clear whether M. D. underwent a second tap water enema at 6:00 a.m.; it appears that her previous discomfort prevented the administration of the second enema. Shortly after 7:00 a.m., M. D.'s condition suddenly deteriorated. Her blood pressure and pulse increased, and her respiration decreased. Her breathing was labored, and her skin became cool and clammy. At 7:57 a.m., a member of the hospital staff telephoned Respondent's answering service and reported M. D.'s deteriorating condition. A minute later, staff summoned an emergency resuscitation team. Two minutes later, staff summoned an emergency cardiac arrest team. However, all attempts to resuscitate M. D. were unsuccessful, and she expired at this time. An autopsy revealed that M. D. died of fecal peritonitis caused by a perforated rectal carcinoma. M. D. had an undiagnosed tumor in her intestinal tract that had killed sufficient tissue so that the intestinal tract had lost its integrity. It is unclear whether the tissue was perforated by the peristalsis caused by the laxative. The mild abnormality in one component of the white blood cell count may have been an early indication of an infection consistent with a spontaneous failure of the weakened intestinal tract, but other white blood cell counts suggest a failure of the intestinal tract long after the administration of the laxative. Clearly, if the weakened intestinal tract withstood the laxative, it could not withstand the cumulative effects of the laxative followed by the tap water enema a few hours later. It is undisputable that the intestinal tract would have failed catastrophically, sooner or later, even without the administration of a laxative or enema. It would have been within the applicable standard of care for Respondent to have sent M. D. home rather than admit her to the hospital. It was within the applicable standard of care for Respondent to visit M. D. anytime within the first 24 hours of her admission to the hospital. It was within the applicable standard of care for Respondent to order a barium enema and tap water enema, even with a gentle laxative, such as the one used. It was within the standard of care for Respondent to treat this case as a simple matter of constipation caused by fecal impaction. The applicable standard of care did not require Respondent to rule out other highly uncommon conditions, such as the loss of tissue due to undiagnosed carcinoma, prior to undertaking the treatment plan that he undertook in this case.
Recommendation It is RECOMMENDED that Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 2nd day of July, 2002, in Tallahassee, Leon County, Florida. ___ ROBERT E. MEALE 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 July, 2002. COPIES FURNISHED: William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Bruce A. Campbell, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Ricardo Torres, Jr., Esquire 7975 Northwest 154th Street Suite 340 Miami, Florida 33016
The Issue Whether Petitioner is entitled to a permit to operate a medical oxygen retail establishment.
Findings Of Fact Petitioner, All Florida Medical Supplies, Inc. located in Delray Beach, Florida, is the applicant for a permit to operate a medical oxygen retail establishment. The application was filed due to a change in the ownership of Petitioner. Respondent, Department of Health (DOH), is the agency authorized to regulate medical oxygen retail establishments, as provided in Chapter 499, Florida Statutes (2008). On November 14, 2007, DOH received Petitioner’s Application for a Permit under Chapter 499, Florida Statutes, to operate as a medical oxygen retailer. The applicant’s address was given as: “601 N. Congress Ave. Bldg. 6 Suite Number 606, Delray Beach, FL 33445.” The handwritten mailing address given appeared to be “128 Van Gown Way, Royal Palm Beach, FL 33411-1580.” The name given for the emergency contact at the mailing address was David L. Ford. On December 11, 2007, and on December 31, 2007, DOH sent letters to the 128 Van Gown address requesting additional information to complete the application. On January 8, 2007, one of the owners of Petitioner, Ellen Gust, sent an address correction to DOH by facsimile, along with a corrected application providing a new address. The corrected address was the 601 North Congress Avenue address. On January 11, 2008, another letter citing an application deficiency was sent to the original Van Gown mailing address not the corrected mailing address. In the meantime, the assigned DOH permitting staff person and Mrs. Gust, for Petitioner, had some telephone and email contacts that eliminated the remaining deficiency. On January 18, 2008, DOH notified Petitioners that is application was complete. A DOH inspector received the completed application from the permitting office and, on February 7, 2008, conducted an inspection of the business at its location at 601 North Congress Avenue in Delray Beach. The inspector saw approximately 60 cylinders of oxygen at the inspection site and determined that they were full, based on the color of the tape used to seal them. She testified that Mrs. Gust told her that the cylinders had been filled on site. The inspector found that the full oxygen cylinders were improperly labeled. That is, the labels on the cylinders lacked the name of the company and location where filled, as required by the Food and Drug Administration’s compressed medical gases guidelines. In addition, the expiration date on the cylinders was December 2007, and there was no way to determine the oxygen content because Petitioner failed to produce any stability testing records. Mrs. Gust told the investigator that the date on the cylinders was the date they were filled. The inspector observed cylinders inside a delivery van that also had an expiration date of December 2007. The lot numbers on the cylinders inside the business and in the van were the same, but the validity of the lot numbers could not be verified by reference to any corresponding business records or fill logs. Mrs. Gust’s husband told the inspector that the lot numbers were the numerical date of the year and month the tanks were filled, which is acceptable except that the methodology was not listed in any of Petitioner’s policies and procedures. Based on the inability to verify that the oxygen was safe and effective for use by patients, or to determine the useful life in the absence of stability test records or fill logs, the inspector ordered the removal of the seals on the cylinders and the release of the oxygen. The inspector also found unclear signage to designate a quarantine area in the warehouse. The inspector recommended, and DOH agreed that Petitioner failed the site inspection and that its permit application should be denied.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law it is RECOMMENDED: That the Department of Health enter a final order denying the application of All Florida Medical Supplies, Inc., for a permit to operate a medical oxygen retail establishment. DONE AND ENTERED this 15th day of August, 2008, in Tallahassee, Leon County, Florida. S ELEANOR M. HUNTER 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 15th day of August, 2008. COPIES FURNISHED: Javier Talamo, Esquire Kravitz & Talamo, LLP 7600 West 20th Avenue, Suite 213 Hialeah, Florida 33016 Jennifer L. Condon, Esquire Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-2202 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
Findings Of Fact On January 21, 1977, respondent was employed as a registered nurse by Mount Sinai Hospital in Miami Beach, Florida. She and Ms. Nancy Sewak were working together in the labor and delivery department of the hospital, attending the single patient under their care that night, a newly delivery mother resting in the recovery room. Respondent had the keys to the narcotics Box. Ms. Sewak heard respondent unlocking the narcotics box, which aroused her suspicions. Shortly after respondent had left it, Ms. Sewak inspected the medicine room and noticed a bottle of sterile water standing by itself on a counter. From the medicine room, she went to the head obstetrics nurse, Ms. Sandra Sazlow Spiegel who, in turn, approached Mr. Ledon, Chief of Safety and Security at the hospital. Ms. Spiegel went to the door of a bathroom where she had been told she could find respondent. When she knocked, respondent answered, "just a minute," and the people standing outside the door heard the toilet being flushed several times. Ms. Spiegel left the vicinity of the bathroom, but Ms. Sewak and Mr. Ledon entered after respondent left and found in the wastebasket a wet alcohol sponge, a piece of Chix with fresh blood spots, and paper towels. Later Ms. Sewak saw respondent in the medicine room holding a 3 cc syringe filled with clear liquid, and asked her what the syringe contained. Respondent answered, "I guess I better label this as 50 mg. of Demerol," and did so. At Ms. Spiegel's request, respondent came to the nursing office where she and Ms. Marcia Fetterman, Assistant Director of Nursing at Mount Sinai Hospital, questioned her. They had a 3 cc syringe which respondent identified as the one she had labelled "50 mg. of Demerol." Ms. Fetterman asked her whether it would be necessary for them to send the syringe to the lab for analysis of its contents. Respondent said that would not be necessary and admitted the syringe contained sterile water. She further admitted that she had injected herself with Demerol earlier in the evening, and had been taking Demerol for over a year. Respondent offered to pay for the Demerol.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That respondent's license, No. 69273-2, be suspended for one year; and thereafter until she shall furnish the Board her affidavit reciting that she has abstained from using Demerol during the period of the suspension. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 21st day of June, 1977. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of June, 1977. COPIES FURNISHED: Lucy A. Pantzer, R.N. 915 N. Wilton Pl. Apt 311 Los Angeles, California 90038 Julius Finegold, Esquire 1005 Blackstone Building 233 East Bay Street Jacksonville, Florida 32201 Helen P. Keefe State Board of Nursing 6501 Arlington Expressway, Bldg. B Jacksonville, Florida 32211
