DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, V. CASE NO. 2015-11011 NIURKA DE LA CARIDAD MOREY, R.PH., RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health ("Department"), by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Niurka De La Caridad Morey, R.Ph., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all times material to this Administrative Complaint, Respondent was a licensed pharmacist within the state of Florida, having been issued license number PS45099.
3. Respondent's address of record is 7422 SW 159th Place, Miami, Florida 33193. 4. At all times material to this Administrative Complaint, Respondent was the prescription department manager (PDM) of record for Dalice Medical Equipment, Inc., d/b/a Dalice Compounding Pharmacy CPermittee"), a special sterile compounding pharmacy located at 7844 SW 24th Street, Miami, Florida 33155. 5. On or about April 14, 2015 the Department conducted a routine inspection of Permittee, and found one or more of the following deficiencies: a. Media fill testing did not simulate the most strenuous or challenging activity to be completed by compounding personnel. b. Respondent failed to ensure Permittee require compounding personnel use sterile gloves while compounding. c. Respondent failed to ensure Permittee conduct fingertip glove sampling of compounding personnel. d. Respondent failed to ensure Permittee immediately cease compounding practices when colony-forming unit ("CFU") populations were found in the anteroom. DOH v. Nfurka De La Caridad Morey, R.Ph. 2
e. Respondent failed to ensure Permittee identify the source of the CFU populations found in the anteroom. f. Respondent failed to ensure Permittee undergo remediation after CFU populations were found in the anteroom. 6. Section 456.072(1)(k), Florida Statutes (2014), provides that failing to perform any statutory or legal obligation placed upon a licensee constitutes grounds for disciplinary action. 7. Section 465.022(11)(a), Florida Statutes (2014), provides that the prescription department manager must ensure the permittee's compliance with all rules adopted under those chapters as they relate to the practice of the profession of pharmacy and the sale of prescription drugs. 8. Rule 64B16-27.797(1)(a), Florida Administrative Code, provides that all sterile compounding shall be performed in accordance with the minimum practice and quality standards of the following chapters of the United States Pharmacopeia CUSP"): Chapter 797, Pharmaceutical Compounding-Sterile Preparations. 9. USP Chapter 797 provides that compounding personnel shall be thoroughly competent and highly motivated to perform flawless aseptic manipulations with ingredients, devised, and components of CSPs. DOH v. Niurka De La Caridad Morey, R.Ph. 3
10. USP Chapter 797 provides that a media-fill test shall be completed at least annually for all compounding personnel preparing medium-risk CSPs. The media-fill test shall be performed under conditions that closely simulate the most challenging or stressful conditions encountered during the compounding of medium-risk CSPs. Once begun, the media-fill test should be completed without interruption. 11. USP Chapter 797 provides that compounding personnel who fail written tests, observational audits, or whose media-filled test vials have one or more units showing visible microbial contamination, shall be reinstructed and re-evaluated by expert compounding personnel to ensure correction of all aseptic work practice deficiencies. 12. USP Chapter 797 provides that compounding personnel shall pass all evaluations prior to resuming compounding of sterile preparations. 13. USP Chapter 797 provides that compounding personnel must demonstrate proficiency of proper hand hygiene, garbing, and consistent cleaning procedures in addition to didactic evaluation and aseptic media-fill. 14. USP Chapter 797 provides that gloved-fingertip testing shall be used to evaluate the competency of personnel in performing hand hygiene and garbing procedures. DOH v. Niurka De La Car[dad Morey, R.Ph. 4
15. USP Chapter 797 provides that viable air samples that contain evidence of microbial growth should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficacy, which shall include an investigation into the source of the contamination. 16. USP Chapter 797 provides that media-fill testing of aseptic work skills shall be performed initially before beginning to prepare CSPs and at least annually thereafter for low and medium-risk level compounding. 17. Respondent,. as PDM of record for the Permittee, failed to perform a statutory or legal obligation by failing to ensure the Permittee's compliance with one or more of the aforementioned rules of the Board of Pharmacy as they relate to the practice of the profession of pharmacy in one or more of the following ways: a. By failing to ensure Permittee require all compounding personnel undergo a complete media-fill test that simulates the most challenging or stressful compounding scenario; b. By failing to ensure Permittee require all compounding personnel undergo environmental sampling; DOH v. Niurka De La Caridad Morey, R.Ph. 5
c. By failing to ensure Permittee require all compounding personnel.appropriately undergo gloved-fingertip testing; d. By failing to ensure Permittee immediately cease compounding practices when CFU populations were found in the anteroom; e. By failing to ensure Permittee identify and remediate the source of the CFU contamination found in the anteroom; 18. Based on the foregoing, Respondent has violated Section 456.072(1)(k), Florida Statutes (2014), by and through a violation of Section 465.022(11)(a), Florida Statutes (2014), by failing to ensure the permittee's compliance with Rule 64B16-27.797(1)(a), Florida Administrative Code. [Remainder of page intentionally left blank] DOH v. Nlurka De La Caridad Morey, R.Ph. 6
WHEREFORE, the Petitioner respectfully requests that the Board of Pharmacy enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this ds-1141 day ofpico'caa- 2018. Celeste Philip, M.D., M.P.H. State Surgeon General and Secretary FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK: Vbgel Sanders DATE: MAR 2 9 2018 IC CHRISTOPHE A. JUFtIC Assistant General Counsel Fla. Bar No. 0099014 Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Telephone: (850) 558-9861 Facsimile: (850) 245-4662 Email: christopher.jurich@flhealth.gov PCP.Meeting: March 22, 2018 PCP Members: Michele Weizer, Jeenu Philip DOH v. Niurka De La Caridad Morey, R.Ph. 7
NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. A request or petition for an administrative hearing must be in writing and must be received by the Department within 21 days from the day Respondent received the Administrative Complaint, pursuant to Rule 28-106.111(2), Florida Administrative Code. If Respondent fails to request a hearing within 21 days of receipt of this Administrative Complaint, Respondent waives the right to request a hearing on the facts alleged in this Administrative Complaint pursuant to Rule 28-106.111(4), Florida Administrative Code. Any request for an administrative proceeding to challenge or contest the material facts or charges contained in the Administrative Complaint must conform to Rule 28-106.2015(5), Florida Administrative Code. Mediation under Section 120.573, Florida Statutes, is not available to resolve this Administrative Complaint. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida. Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. DOH v. Niurka De La Caridad Morey, R.Ph. 8