Findings Of Fact Respondent holds community pharmacy permit number 0007857, which is issued for the location of 7121 West Flagler Street, Miami, Florida 33144. Filimon Galo is the president, and Miriam Galo is the secretary of Gamy Discount Pharmacy, Inc. On December 9, 1985 and on December 11, 1985, investigators for the Department of Professional Regulation conducted a routine pharmacy inspection of Gamy Discount Pharmacy, Inc. They re-inspected Respondent on January 22, 1986. During each of those inspections, Respondent's prescription department was unclean, unsanitary, and overcrowded. During those inspections, the investigators located several outdated medications in the prescription department. Those medications seized on January 22, 1986, bore expiration dates more than 4 months prior to the date of that inspection. Those medications which were seized by Petitioner contained medicinal drugs and are also known as pharmaceuticals. During the January inspection Respondent had no sign displayed stating the hours when the prescription department is open. During each of Petitioner's inspections, the pharmacy had no sign posted concerning generically equivalent drugs. There was no negative drug formulary in the pharmacy at the time of the inspections. On January 22, 1986, the investigators found one container of a prescription drug--prolizin, a medicinal drug-- which was located outside of the prescription department. During the January inspection, no pharmacist was employed at Respondent's pharmacy. During the January inspection, one vial was seized which bore a handwritten label stating "Diabinol." This vial actually contained a generic equivalent of Diabinol. The vial was misbranded in that it was false or misleading by being labeled with the "brand name" instead of the generic name and did not contain the name and place of business of the manufacturer. During the January inspection, a second vial was located which bore no label. This vial contained a medicinal drug Tranxene and was misbranded in that it did not contain the name and place of business of the manufacturer. During the inspections, prescriptions for controlled substances were discovered which did not contain the name and address of the person for whom the controlled substance was dispensed, the initials of the pharmacist filing the prescription, or the date on which the prescription was filled. During the inspections, Respondent pharmacy had no current drug compendium.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, therefore, RECOMMENDED that a Final Order be entered revoking Respondent's community pharmacy permit. DONE and RECOMMENDED this 19th day of December, 1986, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of December, 1986. COPIES FURNISHED: Rod Presnell, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Enrique Miranda, Esquire 2542 SW 6th Street Miami, Florida 33135 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wings S. Benton, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether disciplinary action should be taken against the license of the Respondent, Roger Allen Bowers, to practice pharmacy in, the State of Florida.
Findings Of Fact The Respondent, Roger Allen Bowers, a registered pharmacist in the State of Florida, practiced pharmacy and was the manager of the prescription department at Scotty Discount Drugs at 3620 Blanding Boulevard in Jacksonville, Florida, during the period of time from May 1, 1978, to February 10, 1979. On February 28, 1979, a Complaint and Notice to Show Cause was issued by the Petitioner Board charging Respondent with violation of Sections 465.101(1)(e) and 893.07, Florida Statutes, for permitting improper maintenance of records in that he failed to keep "on a current basis a complete and accurate record of each controlled substance, controlled by Chapter 893, Florida Statutes," at said community pharmacy. Respondent Bowers requested an administrative hearing. Mary Haddad, a pharmacist licensed in the State of Florida and employed at Scotty Discount Drugs during January, February and March of 1979, noticed that large quantities of Percocet-5 were being ordered by Respondent Bowers. Ms. Haddad felt such an order was unusual, inasmuch as she did not fill any prescriptions for this medication during her first month of employment. She checked the pharmacy Schedule II files for a one-month period and found approximately three (3) prescriptions for Percocet-5 during that period. She noticed, however, that numerous narcotic forms were signed by Respondent reordering this medication. Ms. Haddad noted on February 9, 1979, that there was one 500 stock bottle of Percocet-5 on the shelf which was about three- quarters full. She reported her findings to Owen Scott, a supervisor for Scotty Discount Drugs. Mr. Scott considered the communication from Ms. Haddad and called David Hodge, an agent for Petitioner Board, and requested an immediate audit of the pharmacy. After Mr. Hodge's report was filed with Mr. Owen, Mr. Owen terminated Respondent from the employ of Scotty Discount Drugs. David L. Hodge, the inspector-investigator for the Petitioner Board, audited the pharmacy for a period of approximately nine (9) months previous to February, 1979. The audit showed that during the said nine (9) months' period there was a shortage of 17,628 Percocet-5 tablets, 4,097 Percodan tablets, 609 Dilaudid 4 mg. tablets, and 610 Dilaudid 2 mg. tablets. The audit was introduced into evidence without objection. Mr. Hodge made copies of all the order forms for the said nine (9) months' period at Lawrence Pharmaceuticals which had been sent to said firm and were signed by Respondent Bowers. These copies were introduced into evidence without objection. The Respondent properly filled out the forms, signed them, and properly filed the forms on which the narcotics were ordered. He properly filed the prescriptions that were filled. No explanation was given for the discrepancy between the large amount of narcotics ordered by Respondent as the manager of the pharmacy and the small number of prescriptions filled for these narcotics and the absence of these narcotics in the pharmacy at the time of the audit by Mr. Hodge. There were seven (7) licensed pharmacists employed by the pharmacy managed by Respondent. The store in which the pharmacy was located remained locked until unlocked by an employee, and the pharmacy remained locked. Several people had keys to the store, and the licensed pharmacists had keys to the pharmacy. There was a spare key to the pharmacy within the store in the store manager's office under a ledge by a small door next to the pharmacy. The assistant manager of the store, an unlicensed person, knew the location of this key, as perhaps did other people, inasmuch as it was left on the ledge when not in use. Petitioner submitted proposed findings of fact, memoranda of law and proposed recommended orders. These instruments were considered in the writing of this Order. To the extent the proposed findings of fact have not been adopted in, or are inconsistent with, factual findings in this Order they have been specifically rejected as being irrelevant or not having been supported by the evidence.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license of the Respondent, Roger Allen Bowers, be revoked. DONE and ORDERED this 12th day of October, 1979, in Tallahassee, Leon County, Florida. COPIES FURNISHED: Michael I. Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 William J. Sheppard, Esquire 215 Washington Street Jacksonville, Florida 32202 DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675
The Issue At issue in this proceeding is whether Respondent committed the offenses set forth in the Administrative Complaint1 and, if so, what penalty should be imposed.
Findings Of Fact Respondent's licensure and employment Respondent, Nury D. Soler, is now, and was at all times material hereto, licensed as a pharmacist by the State of Florida, having been issued license number PS 0014628. Pertinent to this case, Respondent was the prescription department manager for Westchester Pharmacy for a two-month period extending from some time in October 1996 and at least through December 13, 1996. Westchester Pharmacy is a community pharmacy licensed by Petitioner, pursuant to Section 465.018, Florida Statutes, and located at 7253 Southwest 24th Street, Miami, Florida. The pharmacy owner or permittee was Noriel Batista. The pharmacy inspection On December 14, 1996, a Saturday, Richard Castillo, an investigator employed by the State of Florida, entered the Westchester Pharmacy to conduct a routine community pharmacy inspection. Upon entry, Mr. Castillo observed only one person in the pharmacy, a man later identified as the permittee (Mr. Batista). At the time, Mr. Batista was observed in the vicinity of the prescription area, at the rear of the store. Mr. Castillo proceeded to the counter at the rear of the store, and was approached by Mr. Batista. Thereupon, Mr. Castillo feigned a toothache, and the following events transpired: . . . I put my hands on my face and I said I have some tooth pain, is there anything you can do about it. At which time, he said you really need to go see a dentist. I said that dentists cost a lot of money and that I believed that it was an infection. At which time he came back with a bottle of twenty Amoxicillin, 500 milligram capsules. He sold me the bottle for $10.00 and I gave him the $10.00. He then gave me some preliminary instructions, and went back into the prescription department area. He returned and said that as a gift I'm going to give you these medications; which was four capsules of Motrin 800 milligrams. Amoxicillin is a prescription drug, which Mr. Batista, who was not licensed as a pharmacist, sold without benefit of a prescription. Following the sale, Mr. Castillo identified himself as an investigator, told Mr. Batista he was present to conduct a routine inspection, and asked to speak with the pharmacist. When told the pharmacist was not available, Mr. Castillo asked Mr. Batista to telephone her and ask her to come to the store. Mr. Batista did so, and about an hour later Respondent arrived. Mr. Castillo inspected the pharmacy and completed a community pharmacy inspection report on which he noted a number of perceived deficiencies. (Petitioner's Exhibit 2). First, with regard to Mr. Batista's sale of amoxicillin, Mr. Castillo noted three deficiencies or violations against the pharmacy business, to-wit: (1) there was no pharmacist on duty when the prescription department was open (a perceived violation of Rule 64B16-28.109, Florida Administrative Code); (2) there was no pharmacist present to provide patient counseling, if requested (a perceived violation of Rule 64B16-27.820, Florida Administrative Code); and, (3) since Mr. Batista did not document the sale, Mr. Castillo considered the pharmacy records of dispensing to be incomplete (a perceived violation of Rule 64B16-28.140(3)(b), Florida Administrative Code). Other deficiencies noted by Mr. Castillo against the pharmacy business were as follows: (1) there was no sign displayed that the pharmacy was closed (a perceived violation of Rule 64B16-28.109(1), Florida Administrative Code); (2) the pharmacist's (Ms. Soler's) license was not displayed (a perceived violation of Rule 64B16-27.100(1), Florida Administrative Code); and, (3) there was no sign displayed which stated the hours the prescription department was open each day (a perceived violation of Rule 64B16-28.404, Florida Administrative Code). No further deficiencies were observed and, apart from those noted deficiencies, the prescription department appeared appropriately maintained and operated. Following Respondent's arrival at the pharmacy, Mr. Castillo discussed with her the various deficiencies he had found and had noted on his report. Then, as the "Pharmacist," Respondent signed the report. By signing the report, she acknowledged that "I have read and have had this inspection report and the laws and regulations concerned herein explained, and do affirm that the information given herein is true and correct to the best of my knowledge." Among the information provided on the inspection report was the name of the prescription department manager, which was stated to be the Respondent. Respondent's employment status with Westchester Pharmacy on the date of the inspection Notwithstanding her appearance at Westchester Pharmacy on Saturday, December 14, 1996, and her signing of the inspection report as the Pharmacist for Westchester Pharmacy, Respondent averred, at hearing, that by December 14, 1996, she was no longer affiliated with the pharmacy or responsible for the deficiencies noted. According to Respondent, by December 12, 1996, she had agreed with another pharmacy, Coral Way Pharmacy, Inc., (Coral Way Pharmacy) to serve as its pharmacist effective December 16, 1996, at its pharmacy located at 6965 Southwest 24th Street, Miami, Florida, and that her last date of employment with Westchester Pharmacy was December 13, 1996. While perhaps not entirely free from doubt (given the facial inconsistency between Respondent's contention at hearing and the conclusion one could reasonably draw regarding her association with Westchester Pharmacy, as evidenced by her activities on the date of inspection), the proof demonstrates, more likely than not, that, as Respondent averred, she was no longer employed by Westchester Pharmacy on the day of inspection, her presence on the day of inspection was a matter of accommodation to Mr. Batista, and her signing of the report was a matter of misunderstanding. In so concluding, it is observed that, while the pharmacy was open Monday through Saturday, the prescription department was not open on Saturday, or, stated differently, under the terms of Respondent's employment with Weschester Pharmacy she did not work week-ends. Given that Respondent and Coral Way Pharmacy, reached an agreement on December 12, 1996, for her to begin work at Coral Way Pharmacy on December 16, 1996, it is reasonable to conclude, given the nature of her work-week at Westchester Pharmacy, that her last day of employment with Westchester Pharmacy was Friday, December 13, 1996. Moreover, consistent with the conclusion that Respondent's association with Weschester Pharmacy terminated on December 13, 1996, is the absence of Respondent's wall certificate and license on the date of inspection. Notably, Respondent had not suffered prior disciplinary action in 19 years of practice, and presumably knew that, if employed, she was required to display her wall certificate and license in or near the prescription department. Conversely, she also knew, presumably, that she could not lawfully display them, if she was no longer employed by Westchester Pharmacy. Rule 64B16-27.100, Florida Administrative Code. Since it is presumed that persons will observe the law, the absence of Respondent's wall certificate and license on the date of inspection is consistent with her assertion that, by that date, she was no longer employed by Westchester Pharmacy. Atlantic Coast Line R. Co. v. Mach, 57 So. 2d 447 (Fla. 1952). Finally, also consistent with the conclusion that Respondent's employment with Westchester Pharmacy terminated before the date of the inspection is a statement Respondent made to the inspector. According to the investigator, when asked about the infractions, Respondent stated the following: . . . She said that things needed to change. She asked if she were to leave the pharmacy whether that would change anything, and I said, no, it doesn't matter because you're the pharmacist of record at this point of time. Such statement, when considered in context with other proof of record, discussed supra, is consistent with Respondent having resolved, previously, to terminate her employment with Weschester Pharmacy and, since she did not specifically tell the investigator of her decision, his response evidenced a misunderstanding that resulted in Respondent's execution of the report.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of August, 1998, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK 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 Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 1998.
The Issue Whether Petitioner's renewal application for an assisted living facility (ALF) license should be denied based upon Petitioner's failure of the biennial re-licensure survey conducted on June 10 and 11, 2013, and because Petitioner has a controlling interest in another ALF that has an unpaid fine of $5,000.00 from 2012 after its license was revoked.
Findings Of Fact AHCA is the state agency responsible for regulating home health agencies in Florida. In this capacity, AHCA determines whether to approve applications for renewal of licensure as an ALF, and it has administrative jurisdiction to enforce the laws governing such licensees, including the authority to take disciplinary measures against licensees who violate the applicable statutes and rules. Petitioner is a corporation which operates a 62-bed ALF in the Cannon Point neighborhood of Lauderhill, Florida. The ALF has both a standard ALF license and a specialty limited mental health (LMH) license. Petitioner has been owned and operated for approximately 13 years by Susan and William Spaw. Mrs. Spaw serves as president, administrator, and chief financial officer of Petitioner and owns a 51 percent interest in Petitioner. As such, she is "a controlling interest" of Petitioner as defined by section 408.803(7), Florida Statutes. Mrs. Spaw also was a controlling interest of Serenity Gardens, an ALF which had its license revoked by AHCA by Final Order dated March 30, 2012 (Final Order). By the same Final Order, Serenity Gardens also had a $5,000.00 fine imposed against it by AHCA that remained unpaid as of the date of the final hearing in this proceeding. Florida ALF licenses must be renewed every two years. Petitioner filed an application for license renewal with AHCA which was received on March 20, 2013. When Petitioner's application was received by AHCA, it was referred to Jim Alfred (Alfred), senior management analyst in the ALF licensing unit. Alfred reviewed the application to determine whether any items were missing or anything needed to be added or corrected. On April 12, 2013, AHCA issued an Omissions Letter (Omissions Letter) drafted by Alfred to Mrs. Spaw advising that Petitioner's renewal application was determined to be incomplete and specifying the errors and omissions to be addressed within 21 days to deem the application complete. Among other things, the Omissions Letter states that pursuant to section 408.831, if there are any outstanding fines, liens, or overpayments that have been assessed by final order of AHCA against the licensee or a common controlling interest, they must be paid prior to license/registration issuance. The Omissions Letter indicates that AHCA's records show that, in addition to having a controlling ownership interest in Petitioner, Mrs. Shaw also had a controlling ownership interest in Serenity Gardens which had an outstanding fine in Final Order status for the amount of $5,000.00. The Omissions Letter also notified Petitioner that section 429.14(3), Florida Statutes, gives AHCA the authority to deny the renewal application based upon the revocation of license number 10176, which was issued to Serenity Gardens. As part of the ALF license renewal process, AHCA conducts a biennial "survey." The survey is a comprehensive inspection of an ALF facility and its records to determine compliance with applicable statutes and rules. The survey must be completed before the renewal is issued. During the survey, AHCA surveyors observe staff in their interactions with residents and the dispensing of medications. The surveyors also examine the physical plant and review resident records. When Alfred reviewed Petitioner's application, Petitioner's license was "red flagged" in AHCA's computer system because of the revocation of the license for Serenity Gardens and the outstanding $5,000.00 fine. Alfred brought this to the attention of his supervisor, Shaddrick Haston (Haston), AHCA's unit manager for ALFs. Although either the revocation of the license for Serenity Gardens, a facility in which Mrs. Shaw had a controlling interest, or the outstanding $5,000.00 fine would be a sufficient basis for denial of the renewal application, Haston directed Alfred to wait until receipt of the biennial survey results for Petitioner's ALF before moving forward with a possible denial of the renewal application. The biennial re-licensure survey was conducted at Petitioner's facility on June 10 and 11, 2013, by AHCA surveyors Michael Forrester (Forrester) and Nicolas Frias (Frias). At the time of the survey, both Forrester and Frias were experienced surveyors, each with over approximately 100 inspections, including renewal application biennial surveys. Working together, Forrester and Frias determined there were ten deficiencies, commonly cited as "tags," in reference to applicable regulatory standards. Tag A 010 Tag A 010 cited Petitioner with a violation of Florida Administrative Code Rule 58A-5.0181(4) regarding "Continued Residency." This rule requires that the patient must have a face-to-face medical examination by a licensed health care provider at least every three years after the initial assessment, or after a significant change, whichever comes first. The results of the examination must be recorded on AHCA Form 1823 (Form 1823). A resident observation log revealed that on May 7, 2013, a resident was taken by ambulance to the hospital because she was disoriented, stumbling, drooling, and had slurred speech. Petitioner's staff checked her blood sugar and found it very high. The resident also expressed that she wanted to commit suicide. Although the resident was not diagnosed with diabetes at that time, the resident was determined to have high blood sugar which needed to be monitored by home health services. Neither the change in mental status or physical status was documented on a Form 1823 although each qualifies as a "significant change." Tag A 030 Tag A 030 cited Petitioner with a violation of rule 58A-5.0182(6) and section 429.28 regarding "Resident Care-Rights & Facility Procedures." This deficiency was based upon the observation that the ALF had a pet cat that had no documentation of vaccination since 2009. This was considered to be potentially harmful to the residents. This violation was admitted by Petitioner. Tag A 052 Tag A 052 cited Petitioner with violating rule 58A- 5.0185(3) regarding "Medication-Assistance with Self- Administration." Forrester observed staff assisting residents in the self-administration of medications and saw that the required procedures for unlicensed staff were not followed properly with four residents. A staff member was observed assisting one resident with the application of a medication patch on the resident's abdomen. The staff member did not wear gloves, nor did she wash her hands after providing assistance. Two residents received medication without the staff member first reading the label in the presence of the residents. Staff was also observed leaving a resident before the resident took her medication, in violation of the rule. These violations were admitted by Petitioner, but Petitioner attributed these deficiencies to the staff being nervous due to the presence of the surveyors. Tag A 053 Tag A 053 cited Petitioner with violating rule 58A- 5.0185(4) regarding "Medication-Administration." This deficiency was based upon a review of resident records that reflect an unlicensed staff member performed blood glucose testing on a resident. Upon questioning, the surveyors learned that this was not the only time this occurred because Mrs. Spaw and the staff were unaware that a licensed medical professional is required by the rule to perform this type of procedure. Tag A 054 Tag A 054 cited Petitioner with violating rule 58A- 5.0185(5) regarding "Medication – Records." This deficiency was based on the finding that five out of 28 sampled residents' medication observation records (MORs) were not appropriately maintained. Forrester observed a staff member assist resident 18 with two medications. However that resident's MOR revealed that resident 18 should have been provided with three medications. The staff member noted on the MOR that one of the medications, Risperidone, an antipsychotic medication, was not available. After the surveyor questioned why the resident was not receiving the medication, another staff member found the missing medication. Forrester observed a staff member take a package of medications from a filing cabinet and a pill from one of the packages fell on the floor. None of the same pill type was missing from future doses for resident 13. A review of the MOR for resident 13 showed that one capsule by mouth daily was initialed as being given to the resident from June 1 through June 11, 2013. Because one pill was lying on the floor, it is not possible for the resident to have received all of the prior doses. The MOR for resident 16 showed that this resident was to be given one 800mg tablet of ibuprofen three times a day and had in fact received the ibuprofen as ordered from June 1 through June 10, 2013. However, when staff was questioned by the surveyor regarding why no ibuprofen was available for this resident on June 11, the surveyor was told that the physician had discontinued this order in September 2012. According to staff, the pharmacy erroneously printed the order for ibuprofen on the MOR in June. The deficiency was based upon the fact that staff indicated on the resident's MOR for the first ten days of June that they were assisting the resident with this medication when, in fact, no medication was available. A review of the MORs for residents 21 and 22 indicated that unlicensed staff initialed for providing injections. According to staff, the injections were actually provided by licensed health care providers who came to the facility. At some point later, staff wrote "error." Only the individual who actually provides the injection is to initial the MOR. Tag A 056 Tag A 056 cited Petitioner with violating rule 58A- 5.0185(7) regarding "Medication–Labeling and Orders." This deficiency was based, in part, on the finding that Petitioner failed to ensure that medication orders were followed as directed for 12 out of 28 sampled residents. These 12 residents received their 8:00 a.m. medications after 9:00 a.m. on June 11, 2013. According to the facility's pharmacy, the ideal window for providing medications to a resident would be no more than an hour before and an hour after the required medication dosage time as noted on the MORs. The resident is supposed to take the medications at the time intervals given. The timing issue becomes worse when a resident takes a medication more than once a day. The delay of assistance with self-administered medications for sampled residents by staff is not within the recommended pharmacy time intervals for providing medication assistance at dosage times. The facility's failure to provide physician- ordered medication at prescribed dosage times directly affects the well-being of the sampled residents. On June 11, 2013, Mrs. Spaw acknowledged exceeding the recommended time frame for medication distribution and indicated that it might be due to people coming in late. However, the staff individual who was observed distributing medications late stated that she starts the morning medications at 8:00 a.m. Mrs. Spaw indicated during the survey that she thought the medication distribution was beginning at 7:00 a.m. but she is not at the facility at that time.2/ Tag A 056 was also based upon the observation of a resident who did not receive all doses of medication, despite records indicating that all doses had been dispensed when, in fact, one dose was found on the floor. This deficiency was noted under this tag because it represented a failure to follow the doctor's order of prescribing one dosage per day. Tag A 093 Tag A 093 cited Petitioner with violating rule 58A- 5.020(2) regarding "Food Service-Dietary Standards." This deficiency was based upon Petitioner's failure to follow its own prepared menus. This rule requires that menus are to be dated and planned at least one week in advance for both regular and therapeutic diets. Any substitutions are to be noted before or when the meal is served. A three-day supply of nonperishable food, based on the number of weekly meals the facility has contracted with residents to serve, shall be on hand at all times. The surveyors found that the facility was not providing fruit juice despite fruit juice being on the menu, the menus were not showing a substitution, and the facility did not have a stock of fruit juice available. Petitioner provided no explanation or evidence to rebut this deficiency. Tag A 152 Tag A 152 cited Petitioner with violating rule 58A- 5.023(3) regarding "Physical Plant–Safe Living Environment/Other." In accordance with this rule, residents are supposed to be able to decorate their rooms with their own belongings as space permits. This rule also requires that residents are provided with a safe living environment. This deficiency was based upon the observation that a resident's magazine pictures, which he had taped to the wall of his room, were torn down. This left the walls with missing paint, and they were unsightly. A drain cover for a shower was missing in another resident's bathroom leaving an open hole in the floor which could result in injury to the resident. Petitioner did not dispute this deficiency. Tag A 167 Tag A 167 cited Petitioner with violating rule 58A- 5.025(1) regarding "Resident Contracts." Petitioner is required by this rule to maintain resident contracts that have an accurate monthly rental rate. For two of the 28 residents sampled, the surveyors found that one contract had a rate left blank and another had an incorrect rate. Tag AL 241 Tag AL 241 cited Petitioner with violating rule 58A- 5.029(2) regarding "LMH–Records." This rule requires that a facility with a LMH license maintain an up-to-date admission and discharge log identifying all mental health residents. Review of the facility's records showed that Petitioner had only one admission and discharge log which did not identify mental health residents. This rule also requires that each mental health resident shall have a Community Living Support Plan (CLSP) prepared by the facility administrator and the individual's mental health care provider which identified the specific needs of the resident and a plan for how those needs will be met. The CLSP is to be updated annually. A review of resident 1's records showed that Petitioner only had a CLSP that had been last updated in February 2008. Although the resident had an Interim Mental Health Assessment dated February 18, 2013, it did not reference the CLSP or contain any of its mandatory components. The Exit Interview On June 11, 2013, at the completion of the inspection, Forrester and Frias met briefly for an exit interview with Mrs. Spaw, Assistant Administrator Holli Raven (Raven), and Resident Assistant Marcia Gray (Gray). The purpose of the meeting was to provide a summary of the surveyors' findings and to discuss the Petitioner's responses, if any, to the concerns.3/ Forrestor represented at the meeting that he and Frias believed the deficiencies were all Class III violations but that the determination of classifications was subject to review by their supervisor. Statement of Deficiencies On June 20, 2013, Forrestor hand-delivered to Petitioner a copy of Form 3020, the Statement of Deficiencies, which included a detailed summary of the applicable rules violated and facts supporting the finding of deficiencies. The cover letter indicated that two tags, A 054 and A 056, regarding medication records, labeling and orders, were considered Class II deficiencies. As such, AHCA directed Petitioner to comply with a designated corrective action plan within five days. When delivering the Statement of Deficiencies, Forrestor explained to Mrs. Spaw that the medication-related deficiencies were upgraded by his supervisor from Level III to Level II. Forrestor's supervisor was not physically present at the survey but reviewed the results reported by Forrestor and Frias and upgraded the classifications based upon her training and familiarity as a licensed practical nurse with medication issues. The corrective action plan required Petitioner to provide a medication training course, approved by the Department of Elder Affairs, to staff. It also required Petitioner to ensure all unlicensed staff maintains a minimum of two hours of continuing education training on providing assistance with self- administered medication. The plan also directed Petitioner to obtain the consultation of a pharmacist to ensure all staff providing assistance with self-administered medication is following the guidelines of section 429.256 and that such consultation must be no less than three months in length. Petitioner immediately hired a pharmacy consultant and implemented training for staff. The consultant also reviewed the resident's medical records to make sure they were in compliance with applicable rules. However, Petitioner did not notify AHCA of its compliance efforts nor did AHCA conduct a re-inspection to determine whether the plan was being followed. Mrs. Spaw was very surprised to receive the extensive statement of deficiencies. In particular, she was dismayed that the facility was cited with two Class II violations when the surveyors had indicated at the exit interview that the purported deficiencies were Class III violations. According to Mrs. Spaw, she is not aware of any other facility in her vicinity which has received Class II designations for the types of deficiencies for which her facility is cited.4/ Mrs. Spaw and Forrester had no conversation regarding the findings when he hand-delivered the June 20, 2013, correspondence from AHCA. Mrs. Spaw felt that the survey findings reflected a bias or animus against her facility. However, there was absolutely no evidence of this presented at the final hearing. Both Forrester and Frias testified that they had no prior instruction with regard to how to conduct the survey other than when it was scheduled. They also testified that they conducted the survey at Petitioner's facility in the same fashion that they have conducted numerous other re-licensure surveys. Petitioner did not contest the underlying facts which supported the deficiencies. However, Petitioner suggests that these are relatively minor errors which occurred because a staff member was very nervous due to the surveyors being present and following them while dispensing medications. Notably, the staff person who was involved in the majority of the MOR errors and medication delays did not testify. Petitioner also argues that many of the deficiencies cited are based upon the same facts. For example, there are several deficiencies related to the incident of a pill being found on the floor. However, as explained by Forrester, factual observations may be listed repeatedly because they demonstrate different areas of non-compliance with laws or rules. The same incident may be referenced in support of different tag numbers because there are a variety of laws and rules involved. Notice of Intent to Deny After reviewing the results of Petitioner's re- licensure survey, Alfred met with Haston to discuss Petitioner's re-licensure application. Haston reviewed the results and saw there were two Class II and eight Class III violations. Although Haston wanted Petitioner's facility to remain open because he believes Mrs. Spaw "takes care of patients no one else wants" and there is a need for LMH beds in Petitioner's area, Haston decided to deny re-licensure based upon the failed survey, the outstanding fine from Serenity Gardens, and the fact that the license of Serenity Gardens was revoked. AHCA issued a Notice of Intent to Deny on October 2, 2013, and explained that the denial was based upon the failed biennial re-licensure survey, the outstanding fine imposed by Final Order on March 30, 2012, and that the applicant (Mrs. Spaw on behalf of Petitioner) had a controlling interest in Serenity Gardens, a facility which had its license revoked by Final Order.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order upholding the denial of Petitioner's licensure renewal application. DONE AND ENTERED this 23rd day of May, 2014, in Tallahassee, Leon County, Florida. S MARY LI CREASY 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 23rd day of May, 2014.
The Issue The issue is whether the Respondent violated the statutes and rules as alleged in the Administrative Complaint.
Findings Of Fact Lester Henderson is a pharmacist holding license number 0015985 issued by the Department of Professional Regulation. The Respondent's last known address is 4029 Eastridge Drive, Valrico, Florida 33594. At all times relevant to the allegations contained in the Administrative Complaint, the Respondent was the pharmacist of record at Tampa Park Plaza pharmacy, 1497 Nebraska Avenue, Tampa, Florida 33602. On February 16, 1983, an audit of the Tampa Park Plaza Pharmacy was conducted by the Department. This audit revealed seven prescriptions purportedly issued by Dr. Vinai Artyamsoal for the following amounts Schedule II substances prescribed for Carrie (or Connie) Chambers: 5/18/82 Demerol 50 mg. 100 tabs 8/16/84 Demerol 50 mg. 100 tabs 9/10/82 Demerol 50 mg. 100 tabs 10/8/82 Dilaudid 50 mg. 200 tabs 11/23/82 Dilaudid 4 mg. 200 tabs 12/23/82 Dilaudid 4 mg. 100 tabs 1/20/84 Demerol 100 mg. 100 tabs (See petitioner's Exhibit 3(a) through (g). Dr. Vinai Artyamsoal is a physician specializing in obstetrics and gynecology with offices in Plant City and Zephyr Hills, Florida. Notarized affidavits of Dr. Artyamsoal were received, each of which bears a copy of one of the prescriptions described in paragraph above. Each affidavit contains a statement of Dr. Artyamsoal that he did not issue, authorize, or consent to making the prescriptions depicted within the affidavit. The Board's investigator who is a pharmacist stated "it was a good practice" to check with a doctor to see if the prescription was valid if the doctor was from out of town. (T-52). He also thought a pharmacist should scrutinize such prescriptions more carefully. The Respondent testified that he attempted to contact Dr. Artyamsoal to check on one of the subject prescriptions; however, he was unable to contact the doctor. It was the doctor's practice to personally verify prescriptions with pharmacists by talking with the pharmacist directly. A check of the doctor's records revealed no record for a Carrie (or Connie) Chambers. The Respondent admitted that on April 19, 1983, the pharmacy was unlocked while he was not present at the pharmacy and although he was scheduled to work at that time. There was not an appropriate door or similar structure which could be locked to bar access to the prescription department. There was no sign displayed at said time stating the prescription department was closed. There was a theft of controlled substances from the pharmacy. The Respondent reported this theft to the Federal Drug Enforcement Administration. The Respondent also reported the theft to the state authorities. The Respondent, was one of four partners who owned the pharmacy. The FDEA sent certain forms to the Respondent to be filled out about the theft. The Respondent gave these forms to the partner in charge of business paperwork to fill out. The forms were not sent to FDEA. Because the forms were not returned t FDEA, all of the records were not complete concerning the shortage. The Respondent as the managing pharmacist was attempting to carry the sole work load of this business while working full time at another job which he could not do. This was the reason for the failure to get all of the records complete and be on duty as scheduled.
Conclusions Count I alleges that the Respondent violated Section 465.016(1)(i), Florida Statutes which provides as follows: Compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interests of the patient and is not in the course of the professional practice of pharmacy. This count specifically alleges that the Respondent failed to verify the prescriptions. (See Prehearing Stipulation.) The facts reveal that the Respondent attempted to check the prescriptions on one occasion, and that the Board's own investigator did not say it was unprofessional not to check the prescriptions. It was not alleged and not proven the amounts of the, prescriptions were excessive. Therefore, proof of this Count is wholly dependent upon competent substantial testimony that it is outside the course of professional pharmacy to fill prescriptions without checking with the doctors. The Board's witness did not testify to such a standard. He said it was a good investigative practice to check out of town prescriptions. This is substantially short of stating a professional standard from which a pharmacist cannot depart. This Count was not proven. COUNT II Count II alleges the Respondent was not on duty from 10:15 a.m. until 2:00 p.m., on April 19, 1983 when the pharmacy was inspected. At said time, the pharmacy was not locked and a sign was not posted, contrary to Rule 21S-1.14, FAC, saying the department was closed. This rule says in pertinent part that when a pharmacist is not on duty the pharmacy department is considered closed even if the store is open. When the pharmacy department is closed, a sign shall be displayed saying it is closed. The rule also provides that the pharmacy department shall be locked to prevent entry when it is closed. The Respondent admits that on April 19, 1983 the pharmacy was not locked; that he was supposed to be on duty; that he was not at the pharmacy; that a sign was not so posted; and the pharmacy was not locked. However, the Administrative Complaint does not allege that this violation is punishable under the statute and the rules do not provide a penalty for violation. COUNT III Count III alleges Respondent violated 893.07(1)(b), Florida Statutes by failing to keep all of the records re- quired. The Respondent failed to complete the report of that theft to FDEA, although he reported the theft to federal and state authorities. The Respondent had turned the work over to one of the other partners to be done. It was not done. There was a technical failure to complete the reports to FDEA. The DEA elected not to act upon this violation. Ironically, the Department of Professional Regulation had apparently lost its copies of the Respondent's report of the theft in a move, and the Board did not have all of its records. The Respondent is in technical violation of 465.016(1)(e) MITIGATION The Respondent is a minority business man. He and his partners starred a pharmacy in a predominantly black area of their community. They borrowed money to do this and the Respondent has worked hard; in fact, too hard to make this success. Respondent was working at least one other full-time job and often two jobs to get additional money, for his family to protect the business. Because of this, the recommendation does not levy a civil fine. It does not provide for a suspension which would tend to penalize Respondent who was only one of four partners, at least one other of whom was a pharmacist. It appears many of their violations were the result of Respondent attempting to do too much and inadequate technical knowledge of the rules.
Recommendation Having found the Respondent guilty of a technical violation, as alleged in Count III, it is recommended that the Respondent be placed upon probation for two years during which he would be prohibited from working more than 60 hours per week as a pharmacist or working as a managing pharmacist and be required to take a course on the records required to be kept by Chapter 893 and the Federal DEA. DONE and RECOMMENDED this 24th day of October, 1984 in Tallahassee, Florida. STEPHEN F. DEAN 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 24th day of October, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Lester Henderson 1497 Nebraska Avenue Tampa, Florida 33602 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Dora F. Villanueva is a licensed pharmacist in the State of Florida, holding license number PS 0014957. Ms. Villanueva is an elderly woman who owns the Century Pharmacy, a community pharmacy located at 3017 S.W. 107th Avenue in Dade County, which holds permit number PH 0006839. She depends on the pharmacy for her livelihood and is manager of its prescription department. An investigator for the Department of Professional Regulation, Thomas Daniels, entered the Century Pharmacy in the early afternoon on January 7, 1988. He was there to follow up on a previous inspection of the Century Pharmacy. When Mr. Daniels arrived at the pharmacy, Ms. Villanueva, the registered pharmacist, was not there. It is Ms. Villanueva's practice to open the prescription department from 9:00 a.m. to 1:00 p.m. and 3:00 p.m. to 8:00 p.m. She returns to her home for lunch from 1:00 p.m. to 3:00 p.m. While there, Mr. Daniels, observed a person in the pharmacy department, who was visible through a pass-through window which connects the prescription department with the over- the-counter drug section of the pharmacy. That person was Mary Washington, a pharmacy technician who works at the Century Pharmacy. Ms. Washington is not, and never has been a licensed pharmacist. No other licensed pharmacist was present and on duty at the pharmacy. Ms. Villanueva is the only pharmacist employed at the Century Pharmacy. While Ms. Villanueva was absent, there was no sign indicating the pharmacy prescription department was closed due to the absence of a pharmacist. The records of the Board of Pharmacy admitted into evidence indicate that Ms. Villanueva was placed on probation on November 5, 1984, for one year. The reason for the probation cannot be determined from the records offered in evidence.
Recommendation It is, therefore, RECOMMENDED that Dora F. Villanueva and Century Pharmacy receive a reprimand and a fine of $400 for violations of Rule 21S-1.014, Florida Administrative Code. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 26th day of August, 1988. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1050 (904) 488-9765 Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 1988. APPENDIX Rulings on the proposed findings of fact and conclusions of law of the petitioner. Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 2. Covered in finding of fact 4. Covered in finding of fact 4. Covered in finding of fact 4. Covered in finding of fact 5. Rulings on the proposed findings of fact and conclusions of law of the respondent. Covered in finding of fact 1. Covered in finding of fact 2. Covered in findings of fact 2 and 3. Generally covered in findings of fact 2 and 3. Rejected because I accepted the testimony of Mr. Daniels on this point, that there was no closed sign at all. Whether Dr. Villanueva places a sign in the dispensing window on most days cannot be determined from the evidence, but she did not do so on January 7, 1988. Rejected because I have accepted the testimony of Mr. Daniels that he saw Mary Washington in the pharmacy department. Rejected for the reasons stated in the preceding paragraph. COPIES FURNISHED: Michael A. Mone', Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Regla M. Sibila-Zaidner, Esquire 2260 S.W. 8th Street Suite 204 Miami, Florida 33135 Rod Presnell, Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
