STATE OF FLORIDA DEPARTMENT OF HEALTH

Transcription

1 DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, v. CASE NO LINCOURT COMPOUNDING CENTER, LLC, RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Lincourt Compounding Center, LLC., 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 permitted special sterile compounding pharmacy within the state of Florida, having been issued permit number PH29134.

2 3. Respondent's address of record is 501 South Lincoln Avenue #23, Clearwater, Florida At all times material to this Administrative Complaint, Respondent compounded high risk sterile products. 5. On or about March 21, 2017, the Department conducted an inspection of Respondent's physical location. 6. From the inspection on or about March 21, 2017, the following deficiencies were found: a. The Department's inspection revealed that Respondent failed to have written documentation for specific load items or patterns for the dry heat depyrogenation oven. b. The Department's inspection revealed that Respondent failed to have the external surface of the light fixture smooth side down. c. The Department's inspection revealed that Respondent failed to have the previous two months (January and February 2017) documentation list the agent used for disinfectant. DOH v. Lincourt Compounding Center, LLC 2

3 d. The Department's inspection revealed that Respondent failed to have documented observations of cleaning for personnel responsible for cleaning the cleanroom. e. The Department's inspection revealed that Respondent failed to have nail cleansers in the IV room. f. The Department's inspection revealed that Respondent's compounding personnel repeatedly entered the anteroom (ISO Class 8 environment) without performing the full hand hygiene and garbing process. g. The Department's inspection revealed that Respondent's pharmacist who supervises technicians and signs off on compounded products had not completed a low/medium risk media fill test within the year preceding the inspection. h. The Department's inspection revealed that Respondent failed to have all compounding personnel who engage in high-risk sterile compounding complete a high risk media fill test within the 6 months preceding the inspection. DOH v. Lincourt Compounding Center, LLC 3

4 i. The Department's inspection revealed that Respondent failed to have all compounding personnel complete didactic training on aseptic technique. j. The Department's inspection revealed that Respondent failed to have compounding personnel complete didactic training semi-annually for high-risk products. k. The Department's inspection revealed that Respondent failed to have documentation showing that all compounding personnel completed gloved fingertip testing. I. The Department's inspection revealed that Respondent failed to have documentation showing completion of a visual inspection of compounded sterile products. 7. Section (1)(c), Florida Statutes (2016), provides that the department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee violated any of the rules of the Board of Pharmacy. DOH v. Lincourt Compounding Center, LLC 4

5 8. Rule (1)(a), Florida Administrative Code, provides in relevant part, 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 ("USP"), 36th revision, Second Supplement, incorporated and adopted by reference with the effective chapter dates of December 1, 2013: Chapter 797, Pharmaceutical Compounding-Sterile Preparations. 9. USP Chapter 797 provides that the description of the dry heat depyrogenation cycle and duration for specific load items shall be included in written documentation in the compounding facility. 10. USP Chapter 797 provides that surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability, and minimizing spaces in which microorganisms and other contaminants may accumulate. 11. USP Chapter 797 provides that cleaning and disinfecting agents, their schedules of use and methods of application shall be in accordance with written $0Ps and followed by custodial and/or compounding personnel. DOH v. Lincourt Compounding Center, LLC 5

6 12. USP Chapter 797 provides that mopping shall be performed by trained personnel using approved agents and procedures described in the written $0Ps. 13. USP Chapter 797 provides that the order of compounding garb and cleansing in ante-area shall be: shoes or shoe covers, head and facial hair covers, face mask, fingernail cleansing, hand and forearm washing and drying, non-shedding gown. 14. USP Chapter 797 provides that personnel shall repeat proper procedures after they are exposed to direct contact contamination or worse than ISQ Class 8 air. 15. USP Chapter 797 provides that for medium risk level compounded sterile products compounding personnel shall complete mediafill tests annually. 16. USP Chapter 797 provides that compounding personnel for highrisk level compounded sterile products shall complete a media-fill test semiannually. 17. USP Chapter 797 provides that compounding personnel shall complete didactic training, pass written competence assessments, undergo skill assessment using observational audit tools, and media-fill testing. DOH v. Lincourt Compounding Center, LLC 6

7 18. 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. 19. USP Chapter 797 provides that all employees shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (0 cfu) no less than three times before initially being allowed to compound CSPs for human use. 20. USP Chapter 797 provides that there shall be a visual inspection for abnormal particulate matter and color and intact containers and seals. 21. Based on the foregoing, Respondent has violated Section (1)(c), Florida Statutes (2016), by and through a violation of Rule (1)(a), Florida Administrative Code, which provides in relevant part, 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 ("USP"), 36th revision, Second Supplement, incorporated and adopted by reference with the effective chapter dates of December 1, 2013: Chapter 797, Pharmaceutical Compounding-Sterile Preparations. DOH v. Lincourt Compounding Center, LLC 7

8 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 2nd day of November Celeste Philip, M.D., M.P.H. Surgeon General and Secretary CLERK: DATE: FILED DEPARTMENT OF HEALTH DEPUTY CLERK 03anders NOV /s/ Christopher Jurich CHRISTOPHER A. JURICH Assistant General Counsel Fla. Bar No Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL Telephone: (850) Facsimile: (850) christopher.jurich@flhealth.gov PCP Meeting: November 2, 2017 PCP Members: Michele Weizer, David Bisaillon DOH v. Lincourt Compounding Center, LLC 8

9 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section and , 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 (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 (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 (5), Florida Administrative Code. Please note that mediation under Section , 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 (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. Lincourt Compounding Center, LLC 9