Section Phar 15.38 - Training and evaluation(1) GENERAL. The managing pharmacist, pharmacists, pharmacy technicians, pharmacy interns and pharmacy externs compounding sterile preparations shall successfully complete didactic or practical training. The didactic or practical training shall be done before any compounding personnel initially prepares compounded sterile preparations and annually thereafter and shall include all of the following: (a) Hand hygiene and garbing.(b) Cleaning and disinfection.(c) Measuring and mixing.(d) Aseptic manipulation.(f) Sterilization and depyrogenation.(i) Use of primary engineering controls.(2) EVALUATION. Compounding personnel shall successfully complete an initial and annual evaluation which includes all of the following:(a) Visual observation of hand hygiene and garbing.(b) Visual observation of aseptic technique.(c) Gloved fingertip and thumb sampling.(3) GLOVED FINGERTIP. Successfully gloved and thumb sampling is measured by samplings resulting in zero colony-forming units no fewer than three times. Sampling shall be performed on sterile gloves inside of an ISO Class 5 primary engineering control. Gloved fingertip and thumb sampling in a RABS or an isolator shall be taken from the sterile gloves placed over the gauntlet gloves. When gloved fingertip sample results exceed action levels defined by the pharmacy, a review of hand hygiene and garbing procedures, glove and surface disinfection procedures and work practices shall be performed and documented.(5) RECORDS. The pharmacy shall maintain written policies and procedures for the initial and ongoing training and evaluation of persons involved in compounding sterile preparations. Documentation of all training, assessments, gloved fingertip tests and media-fill simulations shall be maintained by the pharmacy for 5 years and made available to the Board upon request.Wis. Admin. Code Pharmacy Examining Board Phar 15.38
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018