The Issue The issues are whether Respondent withdrew controlled substances from the narcotics dispensing system and failed to document the administration or wastage of those substances; if yes, whether this conduct fails to conform to minimum acceptable standards of prevailing nursing practice; and, if yes, what penalty should be imposed on Respondent's license as a registered nurse.
Findings Of Fact The Department is the state agency charged with regulating the practice of nursing in the State of Florida. Respondent Marla Gunderson ("Respondent") is, and has been at all times material hereto, a licensed registered nurse in the State of Florida, having been issued license number 2832622 by the Florida Board of Nursing in 1994. Respondent was employed by Lee Memorial Health Care System Rehabilitation Hospital ("Lee Memorial") as a registered nurse from about January 29, 2001, until about March 22, 2001. During the first three or four weeks of Respondent's employment, she participated in a full-time training program through Lee Memorial's education department. A part of this training included training in the administration of medications to patients. After completing the three or four-week training program, Respondent began working directly with patients. From about mid-February 2001 through early-March 2001, Respondent had no problems with documenting the administration of medications to patients. Some time in or near the middle of March 2001, Melanie Simmons, R.N. ("Simmons"), Lee Memorial's Nursing Supervisor, received a complaint from the night nurse following Respondent's shift. The complaint alleged that a patient's wife reported that the pain medication her husband was given by Respondent was not the Codeine that had been ordered by the physician. Pursuant to Lee Memorial's policies and procedures, Simmons conducted an investigation into the allegations of the above-referenced complaint regarding the Respondent. Lee Memorial's policies and procedures set out a specific method for conducting investigations regarding the administration of medications to patients. First, the physician's orders are checked to see what medications have been ordered for the patient. Next, the Pyxis records are pulled to determine if and when medications were withdrawn for administration to patients. The Pyxis system is a computerized medication delivery system. Each nurse has an assigned user code and a password, which must be entered before medication can be withdrawn from the Pyxis system. Then, medication administration records (MARs), the documents used by nurses to record the administration of medications to patients, are checked to verify whether the nurse documented the administration of the medications to the patients for whom they were withdrawn. Finally, the Patient Focus Notes, the forms used by nurses to document non-routinely administered medications, are also checked to determine if, when, and why a medication was given to a patient. If after comparing the physician's orders, Pyxis records, MARs, and Patient Focus Notes, it is determined that medications were not properly administered or documented, the nurse making the errors is advised of the discrepancy and given an opportunity to review the documentation and explain any inconsistencies. Simmons' investigation, which included comparing the physician's orders, Pyxis records, MARs and Patient Focus Notes, revealed discrepancies in medications withdrawn by Respondent and the MARs of the three patients under her care. The time period covered by the investigation was March 12 through March 17, 2001. Of the six days included in the investigation period, Simmons determined that all the discrepancies had occurred on one day, March 13, 2001. Nurses are required to record the kind and amount of medication that they administer to patients. This information should be recorded at or near the time the medication is administered. It is the policy of Lee Memorial that should a nurse not administer the medication or the entire amount of the medication dispensed under his or her password, that nurse should have another nurse witness the disposal of the medication. The nurse who serves as a witness to the disposal of medication would then enter his or her identification number in the Pyxis. As a result of that entry, the nurse who observed the disposal of the medication would be listed on the Pyxis report as a witness to the disposal of the medication not administered to patients. Such excess medication is termed waste or wastage. The physician's order for Patient F.R. indicated that the patient could have 1 to 2 Percocet tablets, to be administered by mouth, as needed every 3 to 4 hours. On March 13, 2001, at 14:06 Respondent withdrew 2 Percocet tablets for Patient F.R. However, there was no documentation in the patient's MAR, focus notes, and other records which indicated that Respondent administered the Percocet tablets to Patient F.R. The physician's order for Patient G.D. indicated that 1 to 2 Percocet tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, at 11:18 Respondent withdrew 2 Percocet tablets and on that same day at 17:16, Respondent withdrew another 2 Percocet tablets for Patient G.D. However, there was no documentation in the patient's MAR, focus notes, or any other records which indicated that Respondent administered the Percocet tablets to Patient G.D. The physician's order for Patient T.G. indicated that 1 to 1.5 Lortab/Vicodin tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, Respondent withdrew 2 Lortab/Vicodin tablets for Patient T.G. However, Respondent failed to document on the patient's MAR, focus notes, or other records that the medication had been administered to Patient T.G. With regard to the above-referenced medications withdrawn by Respondent on March 13, 2001, there is no documentation that any of the medications were wasted. All the medications listed in paragraphs 13, 14, and 15 are narcotics or controlled substances. Because Respondent did not document the patients' MARs or focus notes after she withdrew the medications, there was no way to determine whether the medications were actually administered to the patients. Proper documentation is very important because the notations made on patient records inform nurses on subsequent shifts if and when medications have been administered to the patients as well as the kind and amount of medications that have been administered. Without such documentation, the nurses taking over the subsequent shifts have no way of knowing whether medication has been administered, making it possible for affected patients to be overmedicated. Respondent has been a registered nurse since 1994 and knows or should have known the importance of documenting the administration of medications to patients. Respondent does not dispute that she did not document the administration and/or wastage of the narcotics or controlled substance she withdrew from the Pyxis system on March 13, 2001, for the patients identified in paragraphs 13, 14, and 15. Moreover, Respondent provided no definitive explanation as to why she did not properly document the records. According to Respondent, she "could have been busy, called away, [or] got distracted." Following Simmons' investigation of Respondent relating to the withdrawal and/or administration of medications, Respondent agreed to submit to a drug test. The results of the drug test were negative. Prior to being employed by Lee Memorial, all of Respondent's previous experience as an R.N. had been in long- term care. Except for the complaint which is the subject of this proceeding, there have been no complaints against Respondent's registered nurse's license.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order (1) imposing an administrative fine of $250; (2) requiring Respondent to remit the Agency's costs in prosecuting this case; (3) requiring Respondent to complete a continuing education course, approved by the Board of Nursing, in the area administration and documentation of medications; and (4) suspending Respondent's nursing license for two years. DONE AND ENTERED this 1st day of April, 2002, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of April, 2002. COPIES FURNISHED: Reginald D. Dixon, Esquire Agency for Health Care Administration General Counsel's Office-Practitioner Regulation Post Office Box 14229 2727 Mahan Drive Tallahassee, Florida 32317-4229 Marla Gunderson 1807 Northeast 26 Terrace Cape Coral, Florida 33909 Ruth R. Stiehl, Ph.D., R.N. Executive Director Board of Nursing Department of Health 4080 Woodcock Drive, Suite 202 Jacksonville, Florida 32207-2714 Mr. R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact The Respondent is a state agency which initiated a proceeding with the filing of an Administrative Complaint against Marc Richman, D.O. The said complaint was assigned to the Division of Administrative Hearings pursuant to a request for Administrative Hearing pursuant to Chapter 120 and was assigned Division of Administrative Hearing Case Number 88-5258. On June 24, 1989, the Department of Professional Regulations issued a notice of voluntary dismissal in the above captioned proceeding and dismissed all charges against Marc Richman, D.O., in that case. Marc Richman, D.O. is a prevailing small business party within the meaning of Section 57.111(3)(c) and (d). The amount of attorney's fees and cost sought by the Petitioner in the Petition for Attorney's Fees is reasonable for the Representation of Marc Richman, D.O., in the defense of the Administrative Complaint through the date of issuance of the Notice of Dismissal. The Department of Professional Regulation maintains that the proceeds (sic) above-captioned were substantially justified at the time the Administrative Complaint was initiated by the state agency in that it maintains that there existed a reasonable basis in law and fact at the time of the filing of the Administrative Complaint. This position is disputed by the Petitioner, Marc Richman, D.O. The request for attorney's fees in the amount of $8,572.00 and costs of $563.96 for a total of $9,225.96 is reasonable for the representation of Petitioner throughout the instant proceeding. These proceedings were initiated by the filing of a complaint on September 16, 1986 with the Department of Professional Regulation (DPR), Petitioner in Case 88-5258, by the parents of G.H. who died October 18, 1984. G.H. was a long time patient of Dr. Jaffee, D.O. who called in Dr. Richman, an orthopedic surgeon to consult and perform an arthodesis on the left ankle of G.H. to relieve constant pain. G.H. was a 34 year old male accountant who had suffered from juvenile rheumatoid arthritis since the age of 4. Although badly crippled he was able to lead a relatively independent life. As a result of his malady G.H. had for years taken steroid and corticosteroid medications. These medications depress the body's immune system and the ability to fight off infections. Accordingly, G.H. was at more than normal risk anytime he was exposed to infectious diseases. After Petitioner explained the procedure and the risks to G.H., the latter elected to have Petitioner perform the arthodesis. This operation consists of grafting bone into the ankle to stabilize that joint. The donor site chosen for the bone to graft to the ankle was the crest of the left ilium of the patient. This operation was successfully performed on August 2, 1984 at Metropolitan General Hospital, Pinellas Park, Florida. In the hospital on August 9, 1984, while G.H. was being adjusted in his bed, he felt a pop in his left hip and a large hematoma developed over the wound at the donor site. It is not unusual for hematomas to develop over surgical wounds but it is important that such conditions be closely watched because hematomas are a fertile field for an infection. The hematoma on G.H.'s hip showed no evidence of infection and G.H. was discharged from the hospital August 12, 1984 and sent home. Arrangements were made by Petitioner for Robert's Home Health Services, Inc. of Pinellas Park to send a nurse 3 times per week to check on G.H., take his vital signs, dress his wounds and attend to any other medical needs he may have. Verbal reports were made by the nurse to Richman reporting the condition of G.H. While being helped from his wheel chair into bed by his parents on or about August 15, 1984, G.H. apparently fell and caused additional bleeding of the wound on the left hip. On August 16, 1984 the nurse reported to Richman the additional bleeding and she was directed to have G.H. taken to the hospital to be seen by Richman. On August 16, 1984, Petitioner examined the wound, noted the reports that the hematoma was neither inflamed nor more tender, and that G.H.'s temperature had remained normal since the hematoma developed. He sent G.H. back home without further tests. The classic signs and symptoms of infection are redness, swelling, heat and pain. Redness of the skin due to intense hyperemia, is seen only in infections of the skin itself. Swelling accompanies infection unless the infection is confined to the bone which cannot swell. Heat results from hyperemia and may be detected even in the absence of redness. Pain is the most universal sign of infection. Along with pain goes tenderness, or pain to the touch, which is greatest over the area of maximal involvement. (Exhibit 12, Principals of Surgery, Fourth Edition). The hematoma on G.H.'s left hip between its inception and September 13, 1984 never exhibited any sign of infection. On September 6, 1984, G.H. reported to the visiting nurse that he had a pain in his stomach and didn't feel well. The nurse described this as having flu-like symptoms. This was reported to Petitioner and the nurse received no additional orders. On the nurse's next visit on September 10, 1984, G.H. reported his abdomen was still hurting and he didn't feel good. At this time his temperature was elevated at 101. The nurse called Dr. Jaffee's office and was told to have the patient admitted to Metropolitan Hospital. Upon admission to the hospital on September 10, 1984, G.H. was nauseous, vomiting, and had a high fever (103). He had no complaints regarding his ankle or iliac crest and the hematoma had decreased greatly. On September 13, 1984, while G.H. continued showing signs of infection (high fever) Petitioner operated on G.H. to remove the hematoma. At this time aerobic and anaerobic cultures were obtained. Forty-eight and seventy-two hours later these cultures had grown no infectious substance. Further studies and tests revealed that G.H. had bleeding ulcers and surgery was required to patch the ulcers. At this time the spleen was also removed. Following this surgery G.H. was more debilitated and with the precarious condition of his immune system he continued to go down hill until he expired on September 18, 1984. Cause of death was cardiac pulmonary arrest caused by candida septicemia. During the initial stage of the investigation, which was initiated some two years after the death of G.H., the investigator interviewed the parents of G.H., who had filed the complaint, and assembled the medical records including those kept by the home health agency. The parents contended that when the hematoma was removed by Dr. Richman he told the parents that he had found infection at that site. Dr. Richman denies making any such statement to the parents of G.H. and the medical records support the conclusion that there was no infection in the hematoma on September 13, when the hematoma was excised. The parents complained of the treatment that G.H. received from Drs. Jaffee and Richman as well as Roberts Home Health Services. Accordingly the investigation started with both Jaffee and Richman charged with malpractice by the parents of G.H. The investigator selected an orthopedic surgeon, Dr. Richard M. Couch, D.O., from DPR's consulting list and forwarded to him on January 7, 1987, the patient records of G.H. and requested he review those records and give his opinion on whether Drs. Jaffee and Richman diagnoses and treatment of G.H. was appropriate. In this letter (Exhibit 1) the investigator advised Dr. Couch that following surgery a hematoma developed, that after G.H.'s discharge from the hospital the hematoma ruptured and that G.H. was taken back to the emergency room where Dr. Richman saw the patient but found nothing significant about the hematoma. He also told Dr. Couch that when Richman cleaned out the hematoma he advised the family (of G.H.) that infection was found, and that, after this G.H. started internal bleeding which ultimately resulted in the patient's death. Dr. Couch responded to this request with two letters, the first of February 16, 1987 and a second on March 6, 1987. In his first letter Dr. Couch concluded that the iliac wound began draining on or about August 14, 1984 and cultures of this wound were not secured until after G.H.'s hospitalization on September 10, 1984. Since the hematoma was a post-operative complication he opined that Richman failed to adhere to certain tenets regarding wound care in this situation. However, Dr. Couch suggested the records be referred to an internist who reviewed the treatment provided by Dr. Jaffee. In his second letter Dr. Couch opined that Richman was at fault for not incising, debriding and draining the hematoma when it developed and for not taking cultures when Richman saw G.H. in the emergency room on later dates. He also found Richman at fault for not referring G.H. to a consultant in infectious diseases. A letter similar to the letter sent to Dr. Couch was sent by the investigator to Neal B. Tytler, Jr., D.O., an internist. Although the investigator contends he submitted the records maintained by Roberts Home Health Services in this case to Dr. Tytler it is obvious that before he submitted his report on June 5, 1987, Dr. Tytler had not read those records and was concerned regarding the absence of medical records during the period between G.H.'s discharge from the hospital on August 12, 1984, and his readmission on September 10, 1984. In his report Dr. Tytler carefully noted G.H.'s long term medication for juvenile rheumatoid arthritis and the serious side effects, viz depression of the immune system, which results from long-term steroid therapy. Recognizing the risk to G.H. from any surgery Dr. Tytler questioned the wisdom of the arthodesis but recognized that this was more of an orthopedic problem than an internal medicine problem. From the records received, Dr. Tytler concluded that G.H. developed a hematoma after his departure from the hospital and before September 6, 1984. Significantly, Dr. Tytler reported "Of concern to me is the apparent lack of records to document the events which transpired between August 12, 1984 and September 10, 1984. In this one month period an abscess formed at the surgical site and led to disastrous consequences. Unfortunately it can only be inferred that the first recognition of any problem occurred on September 6, 1984, when the patient developed `flu-like symptoms'. He was not examined and no one perceived that his problems were serious." When the probable cause panel met on June 25, 1988 to consider the charges against Drs. Jaffee and Richman, no probable cause was found as to Jaffee. One of the two members of the probable cause panel disclosed at the opening of the panel meeting that he knew Dr. Richman socially and that Richman had been his treating physician for a finger injury. He was excused from further participation and the hearing was tabled regarding Dr. Richman. At a subsequent panel meeting by telephone conference call, after a substitute lay panel member was selected and had been furnished the medical records, a vote was taken to find probable cause. The excerpt from those proceedings (Exhibit 8) shows that the DPR attorney opened the conference call by stating that Richman was charged with medical conduct falling below acceptable minimal standards and "at the last probable cause panel meeting you voted to find probable cause, and asked that administrative complaint be issued. At this time the Department recommends that you do find probable cause to believe that this violation exists." Following receipt of this erroneous information regarding the previous probable cause panel meeting, the Chairman, Mr. Wheeler, stated that after reviewing the entire file he believes probable cause exists to file an Administrative Complaint. Dr. Barker concurred. The case against Dr. Richman began to unravel when the deposition of Dr. Tytler was taken on February 24, 1989. Prior to taking this deposition Dr. Tytler had been provided records from Metropolitan General Hospital, records from Roberts Home Health Services and a copy of the Administrative Complaint. In response to questions regarding the treatment of G.H. as afforded by Dr. Richman, Dr. Tytler stated that a review of all medical records clearly demonstrated that after the hematoma developed at the donor site for the transplant no indication of infection ever appeared; that considering the medical history of G.H. and his high susceptibility to infection it would be more dangerous to the patient to evacuate the hematoma and risk additional infection than it would to continue to observe the hematoma and let it cure itself; that the cultures taken on September 13, 1984, when the hematoma was evacuated clearly and unequivocally demonstrated that the hip wound was not the source of the infection that ultimately led to the demise of G.H.; and that the treatment rendered by Petitioner was in all respects in conformance with required medical standards and procedures. Dr. Tytler further opined that treating an immune compromised patient with antibiotics without a specific infection in mind "could lead to the very scenario that caused his (G.H.) death", namely secondary infection. Further, with respect to the contention of Dr. Couch regarding the failure of Petitioner to take cultures at the hematoma site before September 10, 1984, Dr. Tytler opined that indiscriminate taking of cultures when no evidence of infection is present could result in a positive culture unrelated to the wound but which the doctor would be called upon to treat. This could invite a major change in therapy and an inappropriate prescribing of an antibiotic. Following the deposition of Dr. Tytler, DPR referred the medical records to another orthopedic physician and this doctor concurred with the opinion of Dr. Tytler that Dr. Richman's treatment of G.H. was not below minimally acceptable standards, that no malpractice was involved and that the treatment was in accordance with acceptable medical standards. The Department then dismissed the Administrative Complaint. In his deposition the physician member of the probable cause panel, James H. Barker, D.O., emphasized that his conclusion that probable cause existed to go forward with the Administrative Complaint was significantly influenced by the fact that no culture was done at the hematoma site. From his subsequent testimony it is clear that Dr. Barker was unaware, when he voted to find probable cause, that the culture taken from the hematoma site on September 13, 1984 was negative. The record clearly shows this to be a fact. As stated by Dr. Tytler in his testimony "hematoma yes; infection no." Dr. Barker was also concerned, and perhaps rightly so, that any time that someone goes in for an elective procedure and he dies "that alone makes you think there may be probable cause here." However, there must be factual evidence to support a finding of probable cause and here there was no such evidence.
Findings Of Fact At all times relevant hereto, respondent, Mark L. Klugman, was licensed as an optometrist having been issued license number OP 1758 by petitioner, Department of Professional Regulation, Board of Optometry (Board). He currently resides at 16021 Villa Drive, Hudson, Florida. On or about August 15, 1987 respondent had an occasion to examine Sandra J. Dinkins for the purpose of diagnosing her eyes and to prescribe and furnish contact lenses. She had never previously warn contact lenses. Dinkins selected respondent at random from the telephone directory because his office was nearby and open on Saturdays. At that time, respondent had an office in Tampa, Florida. After being given contact lenses, and making a total of six office visits, Dinkins was unhappy with the lenses and eventually went to another optometrist. A complaint was later filed with the Board, and this culminated in the issuance of an administrative complaint charging respondent with incompetence, gross or repeated malpractice and violating a Board rule. Respondent requested a hearing to contest these charges. According to Dinkins, the contact lenses prescribed by Dr. Klugman caused "total blurriness" and "hurt her eyes." After Dinkins complained about this condition, respondent told her to "wear them for a week and come back." Because she could not see with the lenses, Dinkins was forced to take them out after the first day. On her next appointment, respondent ordered a new left lens. When this did not correct the problem, Dinkins complained again. Respondent told her to keep wearing them and return in a week. This process continued for several weeks until she gave up and went to another optometrist. By this time, Dr. Klugman had ordered another set of lens, but these were never dispensed since the patient did not return. Doctor Klugman suspected that Dinkins' problems were due to the type of lenses he had prescribed rather than the prescription. He acknowledged at hearing, however, that although his suspicion was "logical," it was not correct. He now agrees the patient needed a corrected prescription for astigmatism to resolve her problem. After Dinkins' complaint was filed with the Board, she was examined by a DPR consultant, Dr. John R. Walesby, who has been in the practice of optometry for over thirty years. Doctor Walesby found that respondent's prescription for Dinkins' left eye was in error by 1.00 diopter of cylinder. After obtaining a corrected prescription and new contact lenses, Dinkins' vision measurably improved although she acknowledged she still has a few problems with her left eye. By failing to properly diagnose her acuity, Dr. Walesby concluded that, while respondent exerted a considerable amount of time and effort in trying to fit the patient, he had failed to conform with the minimum standards of optometry in the community. By rule 21Q-3.007 the Board has mandated that, at a minimum, certain procedures be performed by an optometrist while conducting a visual analysis of a patient, and that evidence of the performance of these procedures be recorded on the patient's records. A copy of Dinkins' patient records has been received in evidence as petitioner's exhibit 1. While the Board's complaint charged that respondent violated the foregoing rule in seven respects, at hearing its expert conceded that he had overlooked or misinterpreted certain entries. While the record is less than a model of clarity as to which procedures were performed and recorded on the records, it is found that procedures regarding the family medical history, family ocular history, and visual field testing were not performed or recorded on the records and therefore such deficiencies constitute a violation of the rule. Respondent pointed out that Dinkins could only visit his office on Saturdays and this made reexaminations difficult. However, his principal defense is that the customer wanted a refund and he did not give one, and this prompted the complaint. According to Dr. Klugman, he would not give a refund because the final set of lenses ordered for Dinkins was nonexchangeable and he could not return them to the manufacturer. In addition, he offered various financial records to show that he is heavily burdened with college loans and credit card bills and did not have the financial ability to make a refund. Even so, this does not excuse respondent from complying with Board rules and statutory requirements.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Subsections 463.016(1)(g) and (h), Florida Statutes (1987), that he be fined $1000, and that his license be placed on probation for twelve months under such conditions as the Board may deem appropriate. The remaining charge should be dismissed. DONE and ORDERED this 23rd day of March, 1989 in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 23rd day of March, 1989. APPENDIX Petitioner: Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 6. Covered in finding of fact 4. Covered in finding of fact 3. Covered in finding of fact 5. 7-8. Covered in finding of fact 8 to the extent they are consistent with the evidence. Covered in finding of fact 9. Rejected as unnecessary. COPIES FURNISHED: Laura P. Gaffney, Esquire 130 North Monroe Street Tallahassee, Florida 32399-0750 Mark L. Klugman, O.D. 3611-49th Street North St. Petersburg, Florida 33710 Pat Guilford Executive Director Board of Optometry 130 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
