PURPOSE & INTENT - Compounding Formulas and Technical …



DRAFTED BY:SIGNATORY:n/aTITLE:SIGNATUREDATEVERIFIED BY:SIGNATORY:n/aTITLE:SIGNATUREDATEAPPROVED BY:SIGNATORY:DD MMM YYTITLE:SIGNATUREDATERELATED LOGS & FORMSRECORDSPECIFICATION / DESCRIPTIONF1.070aSterile Hygiene and Garbing AssessmentF1.070aNon-sterile Hygiene and Garbing AssessmentF1.070bAseptic Technique Assessment F1.070bNon-sterile Compounding Technique AssessmentF1.070cSterile Disinfection Competency AssessmentF1.070cNon-sterile Disinfection Competency AssessmentL1.070Practical Skills Training History RELATED STANDARD OPERATING PROCEDURESSOP CODESOP TITLEP0.010Preamble - Implementing - Standard Operating Procedures - Compounding Practice P1.030Personnel - Documenting - Employment - CredentialsP1.050Personnel - Managing - Hazard Communication Program - Compounding PracticeP1.060Personnel – Training – Theoretical Skills – Compounding PracticeP1.080Personnel - Measuring - Performance - CSTD P1.130Personnel - Training - Needlestick Prevention - Sterile Practice P1.140Personnel – Measuring – Performance – Media-Fill ChallengeP1.150Personnel – Measuring – Performance – Finger Tip Touch TestP3.050Procedure - Performing - Mock Recall - Inventory and PreparationsP3.120Procedure - Testing - Environment - SurfaceP5.070Preparation - Performing - Physical Testing - Dosage Units P5.090Preparation - Testing - Protocols - StrengthResponsibilitiesPharmacist-In-Charge oversees this SOP.All compounding personnel must perform practical skills training and performance assessment.All compounding personnel should act as an assessor and be assessed.PurposeTo maintain a high level of performance and related practical skills.ScopeApplies to sterile and non-sterile compounding.Apples to practical skills training of personnel. Applies to personnel competency assessment. DefinitionsNot applicable.FREQUENCYPerform personnel training initially upon hire and routinely on an ongoing at a frequency of:Practical Training ActivityDurationFrequencyPractical skills assessment20-30 minutesEvery two (2) monthsVisual Observation of other personnel20-30 minutesEvery two (2) monthsPerform personnel training in recognition of:Performance-related errors.Trends in traceable root causes of personnel errors. Identified quality, risk and/or verification findings.Environmental changes.Operational changes.Functional changes.SPECIAL CIRCUMSTANCEThis SOP does not apply to personnel theoretical skills training. This SOP does not include fingertip touch tests. This SOP does not include Media-fill challenge testing.PROCEDUREEnsure personnel have completed theoretical skills training to achieve at least the minimum required basic knowledge of compounding in order to complete practical skills training. Ensure personnel complete practical skills assessments in relation to primary and secondary roles and responsibilities. Ensure personnel training utilize auditory and visual instruction techniques. Ensure personnel undergo visual observation by another personnel deemed competent by Pharmacist-In-Charge, or other authorized personnel.Ensure personnel do not perform compounding-related operations until they have successfully completed the practical training and demonstrated appropriate competencies related to their roles and responsibilities subsequent to initial hire or following suspension. Ensure personnel complete practical training and demonstrated appropriate competencies prior to performing new tasks/procedures independently. VERIFICATIONEnsure personnel pass practical skills assessments with a score of 100%.Maintain and analyze the historical compounded preparation sample results of each personnel member to confirm practical skills training is successful. CORRECTIVE MEASURESIf personnel do not pass practical skills assessments with a score of 100%, identify source-of-error and conduct additional practical skills training. If personnel do not pass practical skills assessments with a score of 100%, provide personnel with written and verbal feedback for opportunities for improvements in areas where error(s) were made. If historical compounded preparation sample results of a personnel member reveal room for improvement, consider re-training and additional training. PREVENTIVE MEASURESPersonnel who are documented as being repeatedly late, have incomplete training, or are non-participatory in verbal discussion will be counseled by the Pharmacist-In-Charge or a representative from Human Resources.TECHNOLOGICAL RESOURCESEQUIPMENTMANUFACTURERMAKEMODELSERIAL NUMBERID CODEComplete table ‘TECHNOLOGICAL RESOURCES’, for primary and secondary resources associated with this SOP.Indicate a unique identifier under ‘ID CODE’, for all electromechanical equipment and reusable devices only.SPECIFICATION DOCUMENTSDOCUMENTNUMBERDOCUMENT NAMESOURCEDESCRIPTIONIndicate a ‘DOCUMENT NUMBER’ for filing purposes.Indicate in table ‘SPECIFICATIONS DOCUMENTS’, all SOP-related documentation and their source. REVISION HISTORYREVISION NUMBERIMPLEMENTATION DATETERMINATION DATESUMMARY OF CHANGE TO CURRENT VERSIONIndicate ‘IMPLEMENTATION DATE’ for revision number 1, without ‘SUMMARY OF CHANGE’.Indicate ‘TERMINATION DATE’, in the event a revision has been implemented.Archive terminated SOP.REGULATORY COMPLIANCE GUIDELINESREFERENCE SOURCEREFERENCE CODEREFERENCE DATESECTION CODESECTION DESCRIPTIONUSP79701 AUG 15Pharmaceutical Compounding – Sterile PreparationsUSP79501 AUG 15Pharmaceutical Compounding – Nonsterile PreparationsIndicate multiple ‘REFERENCE SOURCE’ for this SOP.Indicate ‘REFERENCE SOURCE’ as: USP, JCAHO, PCAB, State, Province, or <Other>. ................
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