Conclusions Having reviewed the Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part I], and Chapter 400, Part X, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The parties have since entered into the attached Settlement Agreement, (Ex. 2). Based upon the foregoing, it is ORDERED: 1. The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The facility’s Certificate of Exemption is deemed surrendered and is cancelled and of no further effect. 3. Each party shall bear its own costs and attorney’s fees. Any requests for administrative hearings are dismissed and the above-styled case is closed. 4. In accordance with Florida law, the Respondent is responsible for retaining and appropriately distributing all client records within the timeframes prescribed in the authorizing statutes and applicable administrative code provisions. The Respondent is advised of Section 408.810, Florida Statutes. 5. In accordance with Florida law, the Respondent is responsible for any refunds that may have to be made to the clients. Filed December 24, 2014 3:13 PM Division of Administrative Hearings 6. The Respondent is given notice of Florida law regarding unlicensed activity. The Respondent is advised of Section 408.804 and Section 408.812, Florida Statutes. The Respondent should also consult the applicable authorizing statutes and administrative code provisions. The Respondent is notified that the cancellation of an Agency license may have ramifications potentially affecting accrediting, third party billing including but not limited to the Florida Medicaid program, and private contracts. ORDERED at Tallahassee, Florida, on this 75 day of bam ee , 2014. NOTICE OF RIGHT TO JUDICIAL REVIEW. A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and correct of this Final Ogder was served on the below-named persons by the method designated on this ebrtay of en Lia , 2014. Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 Jan Mills Thomas Jones, Unit Manager Facilities Intake Unit Licensure Unit Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Katrina Derico-Harris Arlene Mayo—Davis, Field Office Manager Medicaid Accounts Receivable Local Field Office Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Shawn McCauley Daniel A. Johnson, Senior Attorney Medicaid Contract Management Office of the General Counsel Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Division of Administrative Hearings Dagmar Llaudy, Esquire (Electronic Mail) Law Office of Dagmar Llaudy, P.A. 814 Ponce De Leon Blvd, Suite 513 Coral Gables, Florida 33134 (U.S. Mail) NOTICE OF FLORIDA LAW 408.804 License required; display.-- (1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency a license authorizing the provision of such services or the operation or maintenance of such provider. (2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued. 408.812 Unlicensed activity. -- (1) A person or entity may not offer or advertise services that require licensure as defined by this part, authorizing statutes, or applicable rules to the public without obtaining a valid license from the agency. A licenseholder may not advertise or hold out to the public that he or she holds a license for other than that for which he or she actually holds the license. (2) The operation or maintenance of an unlicensed provider or the performance of any services that require licensure without proper licensure is a violation of this part and authorizing statutes. Unlicensed activity constitutes harm that materially affects the health, safety, and welfare of clients. The agency or any state attorney may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of the unlicensed provider or the performance of any services in violation of this part and authorizing statutes, until compliance with this part, authorizing statutes, and agency rules has been demonstrated to the satisfaction of the agency. (3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense. (4) Any person or entity that fails to cease operation after agency notification may be fined $1,000 for each day of noncompliance. , (5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s. 408.814 and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation. (6) In addition to granting injunctive relief pursuant to subsection (2), if the agency determines that a person or entity is operating or maintaining a provider without obtaining a license and determines that a condition exists that poses a threat to the health, safety, or welfare of a client of the provider, the person or entity is subject to the same actions and fines imposed against a licensee as specified in this part, authorizing statutes, and agency rules. (7) Any person aware of the operation of an unlicensed provider must report that provider to the agency.
The Issue Whether Emergency Rule 10CER92-4 should be invalidated because it constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Medicaid program is a program authorized under Title XIX of the federal Social Security Act that provides for payments for medical items or services for eligible recipients. Section 409.901(7), Florida Statutes. Prior to July 1, 1993, the Medicaid program was administered by the Department of Health and Rehabilitative Services (HRS). Effective July 1, 1993, Section 20.42, Florida Statutes, 1992 Supplement, was amended by Chapter 93-129, Section 58, Laws of Florida, to give the Agency for Health Care Administration (AHCA) the responsibility for the Medicaid program. The Medicaid program provides for mandatory and optional services to eligible recipients. Prescribed drug services are optional Medicaid services. Medicaid services may be provided only when medically necessary, must be provided in accordance with state and federal law, and are subject to any limitation established by the general appropriations act or Chapter 216, Florida Statutes. Sections 409.905 and 409.906, Florida Statutes. Medical providers participating in the Medicaid program receive reimbursement from Medicaid. Section 409.908, Florida Statutes. States are given the option to charge Medicaid recipients copayments for services. 42 CFR Section 447.50. Certain categories of services and recipients are exempt from copayments. 42 CFR Section 447.53. Forty-five percent of the Medicaid program is funded by state funds and fifty-five percent is funded with federal "matching funds." In order to receive federal matching funds for its Medicaid program, the state must submit a plan describing the nature and scope of its Medicaid program and giving assurances that the program will be administered in accordance with Title XIX and applicable federal regulations. This plan is known as the State plan. Effective February 14, 1992, the Legislature enacted Chapter 92-5, Laws of Florida, which amended the appropriations Act for fiscal year 1991-92. Proviso language in Chapter 92-5 relating to Specific Appropriation 1035 for Medicaid prescribed medicine/drug provides: The Department of Health and Rehabilitative Services is directed to implement, beginning April 1, 1992, a co-payment program for Prescribed Medicine in order to implement spending reductions of at least $770,213 from general revenue and $929,661 from the Medical Care Trust Fund in Specific Appropriation 1035. The State plan was amended effective April 10, 1992, to require a copayment of $1.00 per prescription for pharmacy services provided to Medicaid recipients. Certain categories of services and recipients were exempted from the copayment requirement. Providers were prohibited from denying services to recipients who were unable to pay the copayment. Prior to April 10, 1992, copayments had not been required for prescribed drug services. HRS adopted Emergency Rule 10CER92-4, effective April 10, 1992. HRS published notice of the emergency rule in the Florida Administrative Weekly, Vol. 18, No. 16, April 17, 1992. In this notice under the section entitled "SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE," it states in pertinent part: The 1992 Legislature reduced the prescribed drug services program FY 1991-1992 budget in Senate Bill 2408 which was signed by the Governor on February 14, 1992. This law requires the Medicaid program to implement a copayment requirement for prescription drugs by April 1992. . . . The emergency rule amended Rule 10C-7.042, Florida Administrative Code and required recipients to pay the pharmacy provider a $1.00 co-payment for each prescription or other prescribed drug service reimbursed by Medicaid. Certain categories of recipients and services were exempted from the copayment requirement. The pharmacy provider was required to request a copayment from non-exempt recipients. The pharmacy must determine a recipient's ability to pay the copayment based on the recipient's reply to the request for copayment, the recipient's past purchase history with that provider, and the recipient's recent purchase of non-essential items. A provider could not deny prescribed drug services to eligible recipients because of inability to pay the copayment. Although a recipient may not be able to pay the copayment, the recipient remains liable for the copayment. HRS began the rulemaking process to adopt the same amendments to Rule 10C-7.042 as a regular rule. Emergency Rule 10CER92-4 was challenged via a lawsuit in state court and was later removed to federal court. The proposed amendments to Rule 10C-7.042 were challenged in an administrative rule challenge, which was withdrawn and added to the lawsuit in federal court dealing with the challenge to the emergency rule. Chapter 92-293, Laws of Florida, the Appropriations Act for fiscal year beginning July 1, 1992 and ending June 30, 1993 contains the following proviso language relating to Medicaid prescribed drug services: Funds in Specific Appropriation 1019 are reduced by $18,581,894 from the General Revenue Fund, $3,281,004 from the Grants and Donations Trust Fund, $22,647,089 from the Medical Care Trust Fund, $2,632,000 from the Public Medical Assistance Trust Fund, and $58,013 from the Special Grants Trust Fund for the Department to implement a Medicaid comprehensive cost containment program. This program shall, at a minimum, incorporate: a prior authorization component; a co-payment program; an on site education program for providers prescribing the drugs; enhancements to the Department's ability to identify fraud and abuse; utilization of specific nursing home pharmacy consultants; and, shall implement new electronic technology to speed payments and capture third party liability information. By notice in the Florida Administrative Weekly, Rule 10CER92-4 has been continued pursuant to Section 120.54(9)(c), Florida Statutes. Chapter 93-184, Laws of Florida, the Appropriations Act for the fiscal year beginning July 1, 1993 and ending June 30, 1994, contains no language concerning reductions in the appropriations for Medicaid prescription medicine services and contains no language concerning copayments for recipients receiving Medicaid prescription medicine services. The amounts appropriated for the Medicaid prescription medicine services was at or below the amounts appropriated in Chapter 92-293 Laws of Florida. Chapter 93-129, Section 48, Laws of Florida, created section 409.9081, Florida Statutes, which requires Medicaid recipients to pay nominal copayments for hospital outpatient services and physician services effective July 1, 1993. Prior to the enactment of section 409.9081, Florida Statutes, a one dollar copayment had been required for Medicaid outpatient hospital and physician service. Effective July 1, 1993, the copayments were raised to two dollars. Current revenues generated by the copayments for the Medicaid prescribed drug services is approximately $12 million. Thus, the discontinuance of the copayment would result in a $12 million shortfall for the provision of Medicaid prescribed drug services, and a restriction on services to the extent necessary to account for the shortfall. The Social Services Estimating Conference (SSEC) is a statutorily created body established to develop official information relating to the social service system of the state for use in the state planning and budgeting system. Section 216.136(6), Florida Statutes. Section 216.134(1), Florida Statutes, provides in pertinent part: Unless otherwise provided by law or decided by unanimous agreement of the principals of the conference, all official information developed by the conference shall be based on the assumption that current law and current administrative practices will remain in effect throughout the period for which the official information is to be used. . . . The social services estimating conference for 1993-94 took into consideration the revenues from the copayments for the Medicaid prescribed drug services. Petitioner, Mildred Henry, resides in Jacksonville, Florida, and is disabled. She has received Medicaid since December, 1991. Her only income is Supplemental Income ("SSI") benefits of $434 per month. Ms. Henry suffers from many disabilities including chronic obstructive pulmonary disease, asthma, hypertension, severe and chronic urinary tract infections, and depression. Her physicians have prescribed a number of medications to address these conditions including Cardizem (for high blood pressure), Zantac (for ulcers), Cipro (for chronic urinary tract infections), Phenazopyridine (for bladder problems), Imipramine (for depression), Premarin (hormone), Thes-dur (for asthma), Brethine (for asthma), Ventalin (for asthma), Furosemide (for excess fluid), K-Dur (potassium), Propoxy N (for pain), Nizoral (for skin irritations), Darvoset (for pain), Tylenol 3 (for pain), and Halcion (for anxiety). She needs to refill most of these prescriptions each month. Copayments for all of Ms. Henry's prescription medications amount to $16.00. Ms. Henry's income is below the federal poverty level. She cannot afford to pay a copayment for all her medications. Petitioner has informed her pharmacy that she does not have the money to pay copayments. However, the pharmacy has refused to provide the medications without payment of the co-payments. As a result, Petitioner runs out of medications and delays getting her prescriptions refilled until she can pay the copayment.
The Issue The issues to be determined here concern disciplinary action to be taken against Respondent for those administrative offenses pertaining to the controlled substances Talwin, Dilaudid and Paregoric dispensed by Scottie Drug Store in Duval County, Florida, during the period April 2, 1981, to March 23, 1982, in violation of various provisions of Chapter 465, Florida Statutes. These contentions made by the State of Florida, Department of Professional Regulation, are more particularly described in the Administrative Complaint, DPR Case No. 0022147.
Findings Of Fact Howard E. Staats is a pharmacist who has been issued a license by the State of Florida, Department of Professional Regulation, Board of Pharmacy. The license number is 0007704. At times relevant to this proceeding, Staats practiced pharmacy in Jacksonville, Florida. At all times pertinent to the Administrative Complaint, which is the focus of this action, Staats was the managing pharmacist at American Apothecaries, Inc., which does business as Scottie Drug Store at 41 Arlington Road South, Jacksonville, Florida. A copy of Respondent's most recent license may be found as Petitioner's Exhibit No. 1, admitted into evidence. Petitioner's Exhibit No. 2, admitted into evidence, is a copy of the permit for American Apothecaries. Sometime within the period March 23, 1982, through March 29, 1982, an audit was conducted at the Scottie Drug Store. The audit revealed that in the period April 2, 1981, through March 23, 1982, the drug store had purchased 66,900 tablets of Talwin, 50 mg., had sold 29,373 tablets of that drug, had lost by robbery or theft, 1,000 tablets of the drug, leaving 36,527 tablets of Talwin unaccounted for. During that same audit period, the pharmacy purchased 4,000 tablets of Dilaudid, 4 mg., selling 3,025 tablets of that drug, losing by robbery or theft, 200 tablets of the drug and failing to account for 775 tablets of the drug. Finally, during the audit period, 2,064 ounces of Paregoric had been purchased and 699 ounces sold, with the remaining amount of 1,285 ounces being unaccounted for. See Petitioner's Exhibit No. 4. Talwin is a Schedule IV controlled substance within the meaning of Chapter 893, Florida Statutes. Dilaudid is a Schedule II controlled substance within the meaning of Chapter 893, Florida Statutes. Paregoric is a Schedule III controlled substance within the meaning of Chapter 893, Florida Statutes. The audit which was conducted at the Scottie Drug Store revealed numerous prescriptions for the controlled substance Talwin, 50 mg., written on prescription blanks of Drs. W. W. Shell, Jr., and L. T. McCarthy, Jr., which had allegedly been signed by those physicians, when in fact the patients for whom the prescriptions were written were unknown to the physicians and the signatures of the physicians were forgeries. Those prescriptions are depicted in Petitioner's Exhibit No. 5, admitted into evidence. During the period covered by the audit, it was shown that Staats filled a number of prescriptions for various patients for the controlled substance Talwin, which had been written on prescription pads of Methodist Hospital and Baptist Medical Center in Jacksonville, Florida, and signed by individuals who are not physicians having hospital privileges at those medical centers nor practicing as physicians in the Duval County area. Copies of those prescriptions may be found as Petitioner's Exhibit No. 6, admitted into evidence. In the course of the time sequence related to the audit review process, it was discovered that Staats had refilled numerous prescriptions for controlled substances on more occasions than had been authorized by physicians, namely prescription No. 51632 was refilled twice although the physician indicated there were to be no refills; prescription No. 51579 was refilled once although the prescription indicated there should be no refills; prescription No. 51639 was refilled twice although the prescription indicated there should be no refills; prescription No. 51217 was refilled once although the prescription indicated there should be no refills; prescription No. 51238 was refilled once although the prescription indicated that there should be no refills; prescription No. 53010 was refilled once although the prescription indicated that there should be no refills; prescription No. 53597 was refilled four (4) times although the prescription indicated that it should only be refilled once; prescription No. 53537 was refilled once although the prescription indicated that it should not be refilled; and prescription No. 53592 was refilled twice although the prescription indicated that there should be no refills. Petitioner's Exhibit No. 7, admitted into evidence, is copies of prescriptions spoken to in this paragraph. Respondent Staats had operated the Scottie store under a lease arrangement during 1979 and 1980, and in January of 1981, took a position as an active pharmacist in that store. After becoming the principal operating pharmacist in the Scottie store, Staats began to receive prescriptions from doctors Shell and McCarthy for the substance Talwin and when a prescription purportedly written by those physicians was in question, Staats would call the office of the physicians for confirmation, which at times would be given over the phone and at other times an indication was made that a call back from the physician's office to Staats would be necessary. Some of the indications of physicians' prescription authority of the substances in question would be placed on a separate log and not on the back of the prescription and on other occasions, the note of the prescription information would be placed on the back of the prescription form and not in the log. Normally, this information would be reflected both in the log and on the back of the prescription. There were occasional circumstances in which the authority was not stated in either place. At approximately the same time as was covered by the audit, Staats began to ask for identification from customers who were seeking prescriptions for Talwin and noted that the demand for that substance declined with the advent of the request for identification. Staats posted a notice in the window of the pharmacy to the effect that state law imposed a fine of $5,000.00 or might cause incarceration for five (5) years for presenting forged prescriptions or conspiring or agreeing with another to have a forged prescription filled. On two (2) occasions Staats called law enforcement officials on a circumstance involving suspect prescriptions and those persons were apprehended. (Poor record keeping and mistakes in estimating the amount of losses due to a robbery and a larceny which occurred in the period covered by the audit contributed to the unaccounted for controlled substances, but those matters of record keeping and theft reports would cause only a slight differential in the disparity, as opposed to explaining the whereabouts of a substantial portion of the missing controlled substances.) Beginning on March 25, 1982, Staats began to keep a daily inventory log on the substance Talwin and a number of other controlled substances. A copy of that log may be found as Respondent's Exhibit No. 9, admitted into evidence. In addition, certain out-of-date and otherwise undesirable controlled substances, Schedules II, III and IV, have been removed from inventory and turned over to appropriate authorities for destruction.
The Issue The issue in this case is whether the Board of Medicine should discipline Respondent under section 458.331(1)(g), Florida Statutes (2006),1/ for failures to perform statutory or legal obligations allegedly revealed during an inspection of her medical practice on March 17, 2007. Respondent denies the charges and also defends on the ground of laches.
Findings Of Fact Respondent holds license ME 59800, which allows her to practice medicine in Florida, subject to regulation by DOH and the Board of Medicine. In March 2006, it was noted on Respondent's license that she was a dispensing practitioner, meaning that she could sell or dispense medication. Her medical office at the time was at 5840 Park Boulevard in Pinellas Park. Respondent has been practicing medicine in Florida since 1998. She has not been disciplined by the Board of Medicine. Her practice treats patients for infectious diseases. She often is referred patients who cannot be treated effectively by their regular internists. Although licensed as a dispensing practitioner, Respondent actually has not been operating as a dispensing practitioner. She was not purchasing medications for resale to her patients. (She sometimes gives her patients free samples.) Rather, Respondent stores at her office medications purchased by her patients in large quantities to save money. Sometimes, patients bring their medications to Respondent; sometimes, an online pharmacist sends her patients' medications directly to Respondent's medical practice. Respondent keeps the medications in her office until the patients come in for treatment by infusion or injection. If enough of a reusable medication remains after infusion or injection, Respondent will store the left-over medication, sometimes in a refrigerator or freezer, for subsequent reuse. Respondent has no wholesale contracts for medications and is not affiliated with any manufacturer of medications. Respondent's medical office is in a two-story building. The patient lobby and reception area, Respondent's personal office, and several infusion and examination rooms are on the first floor. The second floor is used to store medications. Every three to four weeks, an employee sweeps the office for expired medications and puts them in storage on the second floor. A biohazard removal service comes to the office once a month to remove and dispose of discarded sharps, used non-reusable medications, and expired medications. DOH conducted a routine inspection of Respondent's medical practice in February 2007. The practice was rated satisfactory in all 28 elements of the inspection, including: clean and safe dispensing area; proper storage of medications requiring refrigeration; expiration/discard date of prescription labels provided in written form; no controlled substances; and outdated medications removed from stock satisfactorily. Respondent's medical practice also was subject to periodic Medicaid inspections and biohazard inspections that were passed satisfactorily. At some time before March 17, 2007, DOH received a complaint that Respondent's patients were being seen and treated by unlicensed medical assistants on Saturdays when Respondent was not present. On Saturday, March 17, 2007, Pinellas Park police and DOH inspectors "raided" the practice. After making sure it was safe to discontinue and postpone patient treatments, DOH ordered all patient treatment to stop and ordered all patients to leave the building. The police officer took photographs of the medical practice. The inspection and photographs resulted in the charges leveled against Respondent in this case. (They also resulted in charges that Respondent facilitated the unlicensed practice of medicine, but DOAH jurisdiction over those charges was relinquished to allow the Board of Medicine to reconsider probable cause.) Findings as to Count I Count I of the Amended Administrative Complaint alleges that Respondent violated Florida Administrative Code Rule 64B16- 28.110 by failing to remove expired and deteriorated medications from her stock of medications at least every four months and by selling or dispensing expired medications. On March 17, 2007, there were some expired and deteriorated medications at Respondent's medical practice. The deteriorated medications were partially or almost completely used medications. In some cases, it was unclear whether the expiration date was a prescription expiration or a medication expiration. One medication bore an expiration date of 1994. There was no rational explanation for how that date came to be on the medication since Respondent was in New Jersey then and was not practicing medicine in Florida until 1998. Except for possibly the mysterious medication bearing the 1994 expiration date, there was no proof that any medications were expired for more than four months. To the contrary, the evidence was that there were no expired medications in storage as of February 7, 2007. Findings as to Count II Count II of the Amended Administrative Complaint alleges that Respondent violated section 499.005(1), Florida Statutes, by storing medications in a freezer that were not supposed to be stored that way, or by possessing legend drugs for which she could not produce pedigree papers. The evidence proved that Respondent stored medications in a freezer that were labeled "refrigerate." The evidence did not prove that those medications were not allowed to be stored in a freezer, or that storage in a freezer would adulterate the medication or render it unfit for use. To the contrary, there was evidence that, for at least one of the medications being stored in a freezer (ceftriaxone, generic for Rocephin), freezing can extend the useful life of the medication for up to 26 weeks. As DOH points out, it cannot be assumed that the same is true of another medication (Azactam) found in a freezer at Respondent's medical practice and labeled "refrigerate." But DOH did not prove that the useful life of Azactam cannot be extended by freezing. DOH proved that Respondent could not produce pedigree papers for any of the medications found at Respondent's medical practice on March 17, 2007. It would not be expected that Respondent would have pedigree papers for medications purchased by her patients from other pharmacies and stored at Respondent's office for their convenience. Those pedigree papers would be held by the pharmacies that sold the medications to the patients. Since Respondent was not acting as a dispensing practitioner, she was not receiving pedigree papers and did not even know what they were on March 17, 2007. Findings as to Count III Count III of the Amended Administrative Complaint alleges that Respondent violated rule 64B8-9.0075 by leaving a syringe, or allowing a syringe to be left, on the counter in the reception area of her office, or by storing or allowing medications to be stored in a refrigerator with uneaten food in a McDonald's bag. Respondent herself was not physically present at her medical office on March 17, 2007, which was a Saturday, before the arrival of the police and DOH inspectors. There was a syringe left on the counter in the reception area of Respondent's office that was photographed by the police officer and seen by him and the DOH inspectors. There was no evidence as to the circumstances of how or when the syringe came to be there. It is possible that it was left there by someone who was interrupted in the provision of medical services by the raid that morning. It was not proven that, as a result of the syringe left on the counter, Respondent was not providing appropriate medical care under sanitary conditions. On March 17, 2007, medications were being stored in a refrigerator with a McDonald's bag that had food in it. There was no evidence as to the circumstances of how or when the bag of food came to be in the refrigerator, but it was unlikely that it was placed there because of the raid that day, and it was inappropriate to store medications in the refrigerator with the food bag. There was other evidence that Respondent's medical practice was not providing patients with appropriate medical care under sanitary conditions. Open vials and injection and infusion devices lay on unsanitary shelves and other surfaces. Refrigerators and freezers where used medications and infusion and injection devices were being stored were not cleaned appropriately. Floors were not cleaned appropriately. However, those items were not specifically charged in the Amended Administrative Complaint. Findings as to Count IV Count IV of the Amended Administrative Complaint alleges that Respondent violated section 456.057, Florida Statutes, by maintaining patient records in an unlocked file cabinet in an examination room, or by maintaining medical records (or allowing them to be maintained) in plain view of anyone who approached the reception area of Respondent's office. DOH proved that there were records stored in an unlocked cabinet in one of Respondent's examination rooms, but it was not proved that they were patient records. Neither the police officer nor any inspector looked at the records to ascertain what they were. Respondent testified that they were administrative records, not confidential patient records. There were patient files left lying on the shelf of the half-door between the patient lobby and waiting area and the reception desk of Respondent's medical practice. There also were open files on the reception desk that possibly could have been seen and read (upside down) by someone standing at the counter in front of the reception desk. These files were photographed by the police officer and seen by him and the DOH inspectors. There was no evidence as to the circumstances of how or when the files got there. It is possible that they were left there by someone who was interrupted in the provision of medical services by the raid that morning. Respondent's Defenses Respondent contends that the photographs taken at her office on March 17, 2007, were "staged"--i.e., that the charges were trumped up by moving or placing items to be photographed (including the McDonald's bag) to make it appear that Respondent was in violation when she was not. The police or DOH investigators did not stage the photographs. Respondent herself testified that she did not believe her medical assistant and other office staff would have done so. That leaves only her medical assistant's boyfriend, who may have been there on March 17, 2007. No plausible reason was given why the boyfriend would have done such a thing (although it is conceivable that he might have placed a McDonald's bag in the refrigerator). Part of Respondent's case that violations were staged was the hearsay of a patient who was there on March 17, 2007. Respondent testified that, when she arrived at the office during the raid, the patient told her she was being "set up," that he saw patient files being placed in open view on countertops and saw someone enter the back door with coffee and food that was placed in the refrigerator. She says he told her that he would testify to what he saw in her defense. Respondent also contends that laches bars the Amended Administrative Complaint because the employee assigned to monitor and discard expired medications and the patient whose hearsay claimed Respondent was set up have died. There was no evidence as to when these individuals died, or why Respondent was unable to preserve their testimony before they died. The Administrative Complaint was filed in March 2008. Respondent requested a disputed fact hearing in April 2008. No evidence was presented at the hearing as to why the matter was not referred to DOAH until February 2012. DOAH files, which can be officially recognized, indicate that at least some of the delay related to settlement negotiations and the consideration of settlement proposals through August 2008. In October 2008 and again in 2011, Respondent's office computer systems malfunctioned, resulting in the loss of digital patient appointment records for March 2007. No evidence was presented at the hearing as to how DOH is responsible for this loss or how the loss of patient appointment records prejudiced Respondent in the presentation of her defense.
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 guilty of one of the violations alleged in Count III of the Amended Administrative Complaint, but not guilty of the other charges; issuing a letter of concern; and imposing a $1,000 fine. DONE AND ENTERED this 4th day of September, 2012, in Tallahassee, Leon County, Florida. S J. LAWRENCE JOHNSTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of September, 2012.
Findings Of Fact The Respondent is a registered nurse holding License No. 0936792 issued by the Florida State Board of Nursing. The Respondent was employed as a registered nurse at Shands Teaching Hospital in Gainesville, Florida, from August of 1978, until April, 1979. Her duties were as a nursing team leader and medication nurse on the fourth floor. The fourth floor unit to which the Respondent was assigned was a 52-to-56- bed unit. Staff on this floor consisted of a charge nurse in charge of the floor and two to four registered nurses. Patient census on this unit ran from 40 to 56 patients. This was a general medical ward whose patients included the chronically ill. (a) Regarding the allegations of Count 1 of the Administrative Complaint related to the patient Gussie Sims Gardner, the hospital records reveal the patient was not admitted to the hospital until 2225 hours on March 24, 1979. The individual responsible for initial preparation of the medication administration record (MAR) did not cross through the times prior to the administration of the patient's first medications as required by the hospital's protocols. See Exhibit 1, Medication Record (Form No. 15-02-41-2), page 2, paragraph 5. Because of this failure, the initial entries for medication administered to the patient on March 25 were transposed to the date of March 24, and the entries for March 26 were placed in the column far March 25. After two days this error was apparently discovered, and no entries were made in the column for March 26. The Respondent cannot be held responsible for this error, because she was not on duty when the patient was admitted. Under the hospital's standard operating procedures (SOP), the first individual administering medication should have crossed out the dates and times in such a manner that this error could not occur. (b) Regarding Counts 1 and 2 of the Administrative Complaint, the Control Substance Form (CSF) does reflect that the Respondent withdrew two Darvon 65, a Class IV controlled substance, on March 25, 1979. The Respondent recorded the administration of the Darvon at the appropriate time but under the date of March 24, 1979. Only the administration of this medication at 0830 hours on March 25 was noted by the Respondent in the nurses' notes. (c) Regarding the allegations of Count 4, recording of the entries for March 25 and 26 under the dates of March 24 and 25 resulted in no entries being made on the MAR on March 26 by any of the nursing staff. (d) Regarding the allegations of Counts 6 and 8 that the physician's order entered March 24 for Oarvom 65 was no longer effective on March 28, Exhibit 1, the Formulary, page VIII, provides that stop orders occur automatically at the end of 48 hours for narcotics and at the end of seven days for all other drugs unless renewed. The Formulary differentiates on page IX between narcotics and other controlled substances. Darvon, while a controlled substance, is not a narcotic and therefore would not be terminated at the end of 48 hours, but at the end of seven days. The administration of this drug by the Respondent on March 28 was not precluded by the hospital's regulations. (e) Regarding the allegations contained in Counts 3, 5, 7 and 9, there is no substantial evidence that the Respondent possessed any controlled substance for any purpose other than the administration of the substance to the patient. No substantial and competent evidence was presented that the medications were not administered to the patient as recorded in the written records of the hospital. (a) Regarding the allegations concerning the patient Mary Lee Love Graham contained in Count 10 of the administrative Complaint, the CSF reflects two doses of Codeine were signed out by the Respondent for this patient on March 25, 1979. The appropriate entries were made on the MAR by the Respondent. Although the 1200 hour administration of medication was charted in the nurses' notes, the administration of the medication at 0830 hours was not charted by the Respondent. Similarly, the administration of Codeine 60 to this patient at 2200 hours was not charted by Nurse Wigginton on March 24, 1979. (b) Regarding Count 12 of the Administrative Complaint, the MAR reflects that Graham received Codeine 60 at 0400 hours from Wigginton and at 0800 hours from the Respondent on march 26, 1979. The nursing notes do not reflect the administration of Codeine 60 at either time. On March 27, 1979, the Respondent apparently administered no medications to this patient; however, the administration of Codeine 60 to this patient at 1600 hours on March 27, 1979, was not charted in the nursing notes. (c) Regarding the allegations of Count 14 in the Administrative Complaint, the MAR and CSF agree regarding the administration of Codeine 60 to Graham on March 26, 1979, at 0800 and 1400 hours by the Respondent. The administration of the medication at 0800 hours was not charted in the nursing notes, as was the administration of the same medication at 2300 hours on the same date by another nurse. Although the physician's orders were not renewed and therefore terminated at the end of 48 hours as discussed above, the MAR was not changed to reflect discontinuation of this medication, and all staff nurses, to include the Respondent, continued to administer Codeine 60 to this patient after the physician's orders ceased. (d) Regarding the allegations contained in Counts 11, 13 and 15, there is no substantial and competent evidence that the Respondent possessed any controlled substance for any purpose other than its administration to a patient. There is no substantial and competent evidence that the medications were not administered as charted. (a) Regarding the allegations contained in Count 16 concerning the patient Marshal Rex Burk, the MAR and CSF records reflect administration of Darvon 65 by the Respondent to this patient at 1000 hours on March 24, 1979. This was not charted by the Respondent in the nursing notes. As stated above, the drug Darvon 65 is not a narcotic drug and not subject to automatic termination at the end of 48 hours. Thee administration of Darvon 65 on March 24, 1979, was pursuant to a physician's order entered on March 19, 1979. (b) Regarding the allegations of Count 18, the CSF and MAR reflect administration of Darvon 65 to Burk at 1000 hours on March 25, 1979, by the Respondent. The Respondent did not chart this in the nurses notes. The physician's order for Darvon remained valid on March 25, 1979. (c) Regarding the patient Burk, the MAR reflects that Dalmane, a Class IV controlled substance, was administered March 21, 22, 23 arid 25 by a staff nurse. The administration of this medication was not charted in the nursing notes, and a review of the physician's orders for this patient does not reflect an order for Dalmane being entered until March 29, 1979. A review of the nursing notes for this patient reveals no charting for March 27, 1979. The SOP for charting provides a minimum of one charting for each patient per shift. (d) The allegations contained in Counts 17 and 19 are not proven. The records reflect the Respondent signed out for Darvon 65 and administered it to the patient. (a) Regarding the allegations contained in Count 20 of the Administrative Complaint concerning the patient Willie Mae Bender Tison, the CSF shows the Respondent signed out for two doses of Darvon 65 on March 24, 1979, for this patient. The MAR reflects administration at 0330 hours on March 24, 1979. The nursing notes do not reflect administration of Darvon 65 to his patient on March 24, 1979. One Darvon 65 was not accounted for in the records. (b) Regarding this patient, his MAR indicates the patient started receiving drugs on March 17, 1979; however, the admitting data and nursing notes reflect that this patient was not admitted until 1450 hours on March 21, 1979. The data contained in the MAR from March 17 until March 24 is clearly in error. (c) Regarding Count 21, although the facts indicate the Respondent did not chart the administration of one Darvon 65 to the patient Tison, no evidence was introduced that the Respondent took the medication herself or retained the medication for sale or distribution. (a) Regarding the allegations in the Administrative Complaint contained in Count 22 relating to the patient Frances Louise Blocker Medina, the MAR reveals that Percodan was administered to this patient on March 24, 1979, at 0530 hours, 0930 hours by the Respondent, 1300 hours by the Respondent and 2200 hours. The CSF reflects that the Respondent withdrew two doses of Percodan for the Respondent on March 24, 1979. The Respondent recorded the administration of the medication to this patient at 1300 hours in the nursing notes. No entries were made in the nursing notes for March 24, 1979, reflecting the administration of Percodan at 0530 hours, 0930 hours and 2200 hours by the Respondent and others. (b) Regarding the allegations of Count 24, the MAR reflects that the Respondent administered Percodan to this patient at 0700 hours and 1100 hours on March 25, 1979. The Respondent charted the administration of this medication to this patient in the nursing notes at 0730 hours and 1030 hours. The CSF shows the Respondent signed out for two Percodan for this patient on March 25, 1979. The MAR also reveals that this patient received Percodan at 1830 hours on March 25, 1979, from another nurse. The nursing notes do not reflect charting of this medication. (c) Regarding the allegations in Count 26, the CSF reflects that the Respondent signed out for two doses of Percodan for this patient on March 26, 1979. The MAR reflects administration of Percodan to this patient at 0200 hours, 0800 hours by the Respondent, 1400 hours by the Respondent and 2000 hours on March 26, 1979. The nursing notes reflect only the administration of this medication for 2000 hours. (d) Regarding the allegations of Count 28, the medical records of this patient reflect that staff nurses, to include the Respondent, continued to give the patient Percodan, a narcotic, although the physician's order for this medication automatically terminated. (e) Regarding the allegations of Count 30, the MAR and CSF reflect that the Respondent administered one Percodan to this patient on March 28, 1979. The Respondent failed to chart the administration of this medication to this patient in the nursing notes. (f) Regarding Counts 23, 25, 27, 29 and 31, no substantial and competent evidence was presented that the Respondent maintained possession of any drug. The records reflect that all drugs signed out by the Respondent were administered to the patient. (a) Regarding allegations contained in Count 32 of the Administrative Complaint concerning the patient Ruby Lee Denson Standback Woodburne, the times on the exhibit copies of the CSF are illegible. However, the MAR and CSF do reflect that the Darvon 65 checked out for this patient by the Respondent on Marcy 24, 1979, was administered to the patient. The nursing notes reflect administration of the medication to the patient. (b) Regarding the allegations in Count 34, the CSF shows the Respondent signed out for Darvon 65 two times on March 25, 1979, for this patient. The MAR reflects the Respondent administered Darvon 65 to the patient at 0830 hours and 1200 hours. The nursing notes reflect that Darvon 65 was administered at 1200 hours but not at 0830 hours. (c) Regarding the allegations of Count 36, the MAR and CSF records show the Respondent medicated the patient at 0800 hours and 1200 hours on March 26, 1979, with Darvon 65. The Respondent charted the administration at 1200 hours in the nursing notes but failed to chart the administration at 0800 hours. (d) Regarding the allegations of Count 38, the CSF reflects the Respondent withdraw one Darvon 65 for this patient on March 27, 1979. The MAR does not reflect administration of this medication; however, the nursing notes reflect the administration of Darvon at 0830 hours on March 27, 1979. (e) The medical service orders for this patient were renewed March 22, 1979, after Use patient's surgery. Presumably, this would have renewed the Darvon 65 order of March 17, 1979, and it would have been effective through March 29, 1970. (f) Regarding Counts 33, 35, 37 and 39, there is no evidence that any medication was net administered to the patient as reflected in the records. Although the MAR entry was not made on March 27, 1979, a nursing note does reflect administration of Darvon 65 on that date by the Respondent. (a) Regarding the allegation contained In Count 40 of the Administrative Complaint concerning the patient Willie Mae Hair, the CSF and MAR records reflect the Respondent administered Darvon 65 to this patient at 0830 hours on March 24, 1979. No entry was made in the nursing notes by the Respondent for this date. Although the patient was discharged on March 24, she was medicated for pain in the evening of March 23, and the nursing note for 0145 hours of March 24 reflects that the nursing staff apparently expected her to experience pain. (b) There is no substantial and competent evidence to support the allegation of Count 41. All medications checked out by the Respondent for this patient were administered according to the records. Regarding Count 42 of the Administrative Complaint, Exhibit 11 reveals that on several occasions the Respondent wasted medications without the required countersignatures of another staff member. There was no substantial and competent evidence presented that the Respondent converted any of the drugs wasted to her own use. To the contrary, although improperly witnessed, the records reflect that the medications were wasted. Review of Exhibit 1, containing extracts of the hospital's SOP's for controlled substances and charting, does not reveal any requirement that the specific time of withdrawal of a controlled substance be entered on the CSF. Exhibit 1 does reflect that medication may be prepared and placed upon a lockable medicine cart. The nature of the entries on the MAR reflect that medications were drawn at one time from the controlled substance container for administration to patients during a shift. The SOP for charting nursing notes does not require that the administration of medication be noted. However, the SOP for administration of medication would require noting the patient's complaint and the patient's response to medication in the nursing notes if a prn medication were administered. Gross departures from the hospital's SOP's regarding controlled substances and charting of nursing notes occurred among staff nurses employed on the fourth floor at the time in question due to staffing shortages.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer would recommend that no action be taken against the Respondent. DONE and ORDERED this day of January, 1980, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Michael I. Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Irving J. Whitman, Esquire 9595 North Kendall Drive, Suite 103 Miami, Florida 33176 Geraldine B. Johnson, R. N. State Board of Nursing 111 Coastline Drive East, Suite 504 Jacksonville, Florida 32202
