Sterile Compounding Safety

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1 Sterile Compounding Safety I International Congress on Patient Safety ISMP Brazil and V International Forum on Patient Safety: Medication Errors Eric S. Kastango, MBA, RPh, FASHP President/CEO Clinical IQ, LLC and CriticalPoint,LLC Madison, NJ and Gaithersburg, MD

2 Learning Objectives Describe factors involved in sterile compounding medication errors Discuss the importance of quality control procedures in order to ensure patient safety List the critical compounding steps necessary to achieve a sterile compounding state of control 7/22/2014 2

3 "Each problem that I solved became a rule which served afterwards to solve other problems." - Rene Descartes ( ), "Discours de la Methode"

4 Risk points for the preparation of CSPs* Prescribing/Communication Technology/Automation Product production Product checking Environment Observations and analysis presented based on data from the ISMP Medication Error Reporting Program (MERP) and onsite ISMP risk assessments across the US * Compounded Sterile Preparations (CSPs)

5 Risk related to Prescribing/Communication Open formulary No restrictions on prescribing Use of non-standard concentrations custom formulations ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

6 Risk related to prescribing/communication Handwritten orders Legibility Dangerous abbreviations and dose expressions Ambiguous orders No preprinted templates/inadequate order sets No requirement for dose in m 2 or mg/kg and total dose ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

7 Risk related to prescribing/communication Products ordered in g, mg, mcg, meq, ratio, percent, ml, units, etc. Alignment of ingredients on order forms does not follow sequence of the order entry into a database Turnaround time expectations (standard vs. custom preparation)

8 Risk related to technology/automation Using manual processes when automation is available Lack of/outdated clinical decision support in order verification, drug selection, and production ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

9 Risk related to Production Not using commerciallyavailable products when available Maintaining only one strength of a product when multiple strengths are available No preparation ticket or directions (worksheet) for compounding; preparation from memory ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

10 Risk related to Production No restrictions on time of day for ordering/production Using the label to prepare IV compounded solutions (not the original order) Lack of standardization of preparation procedures between technicians and pharmacists ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

11 Risk related to CSP production More than one patient-one product in the hood or isolator Flawed labeling procedures Low volume (rarely prepared) solutions made in house Lack of clinical expertise for specialty products ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

12 Risk related to CSP checking Variable checks Before the product is prepared Any dilutions, if required, are checked Before it is added to the placed in the solution After compounding using a syringe pull back After compounding using the vial After compounding writing the volume on the label ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

13 Risk related to CSP checking Lack of technology to test solutions specific gravity, photometric analyzers, weighing of final solutions ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

14 Risk related to the environment Number of distractions during the order review and preparation of products Variable workflow (individual based) Variable production speed ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

15 Risk related to the environment Insufficient space Inadequate storage space Inadequate counter preparation space Hood space/number of hoods for amount of production Shared space in hood or isolator Inadequate space for checking process ClinicalIQ content , ClinicalIQ, LLC - all rights reserved

16 USP Compounding Standards USP Chapter <797>: Sterile Compounding became official on January 1, 2004 Revised chapter official on June 1, 2008 Nationally enforceable Shall vs. Should: Appendix I USP Chapter <795>: Nonsterile Compounding ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

17 Achieving a State of Control Hand Hygiene, Garbing, Aseptic technique Training Facility design, Environmental Control Environmental Sampling Cleaning Standard Operating Procedures Components Sterilization, Quality Release Checks ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

18 Hand hygiene is paramount to safety when preparing medications! ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

19 Hand Hygiene Hand washing is defined as the vigorous, brief (30 seconds) rubbing together of all surfaces of lathered hands, followed by rinsing under a stream of water. Hand washing suspends microorganisms and mechanically removes them by rinsing with water. Single most important way to reduce the risks of transmitting germs Even after using anti-microbial soap, there is still about 20,000 microbes per sq. mm ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

20 Ability of Hand Hygiene Agents to Reduce Bacteria on Hands % 99.9 Time After Disinfection log minutes 3.0 Bacterial Reduction Alcohol-based handrub (70% Isopropanol) Antimicrobial soap (4% Chlorhexidine) Plain soap Baseline Adapted from: Hosp Epidemiol Infect Control, 2 nd Edition, 1999.

21 Compounding Personnel Hair net Beard cover and face mask Gown Nonsterile Gloves Sterile Shoe covers ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

22 Importance of Garbing Used with permission: Particle Measuring Systems ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

23 Is this an example of proper garbing? A Yes B No ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

24 Ensure a Knowledgeable, Engaged Maximize the unique skills and qualities of each staff member. Comprehensive orientation Ongoing training related to job activities Continual competency verification Reward staff who identify near misses and make proactive suggestions for improvement. Workforce Create a Quality Culture! ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

25 Environmental Controls Aimed at creating ISO 5, 7, and 8 environments ISO 5 LAFW, BSC, CAI, CACI are Primary Engineering Controls Must maintain ISO 5 during dynamic (in use) working conditions Unidirectional airflow required ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

26 Environmental Controls ISO 7 buffer area and ISO 8 ante area are Secondary engineering controls Must maintain ISO 7 or 8 during dynamic (in use) working conditions Airflow and balance testing required at the installation site Only personnel and materials essential for compounding and cleaning are permitted ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

27 Primary Engineering Controls Laminar Air Flow Workbench ( Hood ) ISO Class 5 Primary Engineering Control (PEC) Biological Safety Cabinet ( Hood ) Compounding Aseptic Isolator ( Glovebox ) Images courtesy ClinicalIQ, LLC. Direct Compounding Area (DCA) ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

28 ISO classification The smaller the number, the cleaner the air Refers to number of particles allowed per volume of air PEC = ISO 5 Buffer area = ISO 7 Ante area ISO 8 if it opens only into a positive pressure cleanroom ISO 7 if it opens into a negative pressure cleanroom Air Cleanliness

29 Cleanliness Classification Comparison Class limits for sterile compounding based on the number of particles 0.5µm per m 3 (ISO) or per ft 3 (former Federal Standard 209E) Count locations are determined based on room size and classification and are measured under dynamic operating conditions. ISO Class US FS 209E ISO m 3 FS 209e (ft 3 ) 3 Class Class Class Class , Class 10, ,000 10,000 8 Class 100,000 3,520, ,000 Copyright CriticalPoint - All rights reserved

30 Surround the DCA with layers of protection Primary Engineering Control Buffer Area Ante Area Stockroom Direct Compounding Area (DCA) Images courtesy BD Medical Systems and Clinical IQ,LLC. ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

31 Decontamination/Disinfection Transfer of material into and out of the primary engineering controls is one of the greatest potential sources of contamination. Routes include bags, boxes, paper and markers Research has shown that: 60% of consumables are contaminated with bacteria 40% of consumables are contaminated with bacterial spores Spraying alone is not enough Organism Spray Spray + Wipe Aspergillus Niger 84% 98.5% Bacillus subtilis 27% 94% M. G. Cockcroft, D. Hepworth, J. C. Rhodes, P. Addison, A. M. Beaney. Validation of Liquid Transfer Disinfection Techniques for Transfer of Components Into Hospital Pharmacy Cleanrooms, Hospital Pharmacist (September, 2001).

32 Contaminated Material Sample testing of items routinely used in isolators Item % contaminated % Bacillus (spores) Syringe package Swab package Needle package Sharps bin M. G. Cockcroft, D. Hepworth, J. C. Rhodes, P. Addison, A. M. Beaney. Validation of Liquid Transfer Disinfection Techniques for Transfer of Components Into Hospital Pharmacy Cleanrooms, Hospital Pharmacist (September, 2001).

33 Environmental Sampling Environmental Sampling section has been separated into a facility-related performance metric and a personnel related performance metric Facility-related Environmental Sampling Viable air sampling via volumetric method (impaction) to occur at least every 6 months Personnel-related Environmental Sampling Personnel fingertip sampling during initial training, with media fills and as a competency assessment tool Surface sampling for viable microorganisms

34 General Environmental Sampling Shalls Detailed written PnP on all aspects of environmental sampling Sampling occurs in all ISO areas from cleanest to dirtiest ISO 5 ISO 7 ISO 8 CFU Action Levels established Table 2 in Chapter <797> Volumetric Classification Air Sample Required* ISO Class 5 > 1 ISO Class 7 > 10 ISO Class 8 > 100 Evidence of logical plan of action in the event sampling exceeds Action Levels CFU/m 3 air/plate(1000 liters) If < 1000 liters air sampled, convert to equivalent AL (e.g., 400 liter sample in ISO Class 7 then AL = >4 CFU/plate)

35 Growth Media Soybean Casein Digest Media (Trypticase Soy Broth/Agar) to support the growth of bacteria Malt Extract Agar or other media that supports the growth of fungi Must use plates with lecithin and polysorbate 80 which are chemicals that neutralize cleaning agents when performing: Surface sampling Personnel glove sampling associated with MFUs

36 Sampling for Air Viable Organisms Volumetric air sampling is required Predefined amounts of air Settling Plates cannot be the only method of evaluating air viable organisms Not qualitative Settling of particles influenced by size of particle and air movement Courtesy of MSI, Inc. Houston, TX (

37 Environmental Sampling Designed to demonstrate that the primary and secondary engineering controls, disinfecting procedures, and work practices result in a suitable environment for aseptic compounding Utilizes several approaches to assess and evaluate: Total particle counts Air viable organism cfu Surface viable organism cfu Finger touch plates ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

38 What is the difference between cleaning, sanitization and disinfection? Cleaning Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Sanitizing Chemical process of reducing the number of disease-causing germs on cleaned surfaces to a safe level. Disinfecting Disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects. ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

39 Cleaning and Disinfection Routine cleaning & disinfection decreases the overall bioburden in the compounding area therefore reducing the risk of contamination to CSPs. It is one part of an overall quality management plan. Other components include: Design/function of primary and secondary engineering controls Material/component handling procedures Personnel hand hygiene and garbing Environmental sampling/testing Images courtesy ClinicalIQ, LLC. ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

40 More than Daily* Daily Monthly ISO Class 5 PEC & work surfaces Beginning of day/shift Prior to each batch Every 30 min When visibly soiled As spills occur Suspect contamination Empty trash as needed Cleaning and Disinfection Empty trash ISO Class 5 PEC** Easily cleanable horizontal surfaces in ante and cleanrooms (including passthrough counter) Restock daily supply cart Floors from furthest location in cleanroom out thru anteroom (including pass-through floor) Empty trash Ceiling Walls, Pass-throughs Every surface Outside of PECs All carts (top, bottom, wheels, etc.) Supply bins Doors, handles, vents ISO Class 5 PEC** Restock supply cart Floors (same as daily) Clean refrigerators, freezers, incubators, etc. * Clean PEC with sterile 70% IPA ** Clean with germicidal detergent diluted with SWf Irrigation followed by sterile 70% IPA; use decontamination first agent if HD PEC Red represents best practice recommendation; Black indicates 797 required ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

41 Considerations for Training Program Any new sterile compounding standard changes ingrained behavior Research shows that training plays a big role in changing ingrained behaviors, particularly if new practices are different from what people know from the their experience Some compounding processes have critical steps or precise order. Training does two things: explain why it needs to be done correctly (rationale), and how to do it (process) ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

42 Standard Operating Procedures Requires formalized policies, processes and procedures used in preparing CSPs One element of quality that may not be routinely performed in pharmacies is documentation, or written proof that compounding occurring properly ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

43 Understanding all of the elements Risk Level Beyond-Use Dating (point in time) Chemical Stability Microbial Stability Aseptic technique ASSUMPTION! CSP is stored at its optimal temperature at all times. Due to the inherent low probability that a Sterility Test can detect low levels of contamination in a batch, sterility assurance must always be based on process design and control. ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

44 Training Personnel Related Metrics Environment Related Metrics Training & Competency Verification Fundamental Principles Aseptic Technique/Media Fill Units with GFS Hand Hygiene/Garbing/GFS Conduct inside ISO environments Cleaning/Material handling SOPs Garbing Head, face, shoe covers Hand hygiene Gown/Frock Application of alcohol based hand rub w/persistent activity Sterile Gloves Sterile Alcohol Component Type (sterile/nonsterile, PBP, SDV, MDV, bulk API) Material Handling Processes Formulary Development Drug/Supply Procurement Standardization of compounding practices and batch records Inventory control Staging/Double-check Sanitize components Area Clearance Reconciliation Labeling, Storage, Transport Selection cleaning and disinfecting agents Equipment and supplies Program of cleaning activities Documentation Viable Sampling 1. Gloved Fingertip Sampling (GFS) 2. Surface Sampling 3. Volumetric Air Sampling Primary/Secondary Engineering Control Certification Non Viable Particle Counts Sterilization Cycle Verification Filter integrity testing Final release checks Air Cleanliness via HEPA, ACPH, & Pressure Differential/Displacement Process verification with media Facility Design Requirements Calibration & Use CSP Testing Strength (Potency) Testing Sterility Testing Bacterial Endotoxin Testing Documentation Materials/Construction Equipment Maintaining a Sterile Compounding State of Control Components & Materials Cleaning & Disinfection Process Control Metrics ClinicalIQ Content Copyright ClinicalIQ, LLC - all rights reserved

45 Excellence is an art won by training and habituation. We do not act rightly because we have virtue or excellence, but we rather have those because we have acted rightly. We are what we repeatedly do. Excellence, then, is not an act but a habit. Aristotle

46 Thank you My contact information: Eric S. Kastango, MBA, RPh, FASHP Clinical IQ, LLC 235 Main Street, Suite 292 Madison, NJ

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