Surface Contamination

Processes to Address Surface Contamination A Midday Symposium and Live Webinar conducted at the 52nd ASHP Midyear Clinical Meeting and Exhibition Monday, December 4, 2017 11:30 a.m. 1:00 p.m. Orlando, Florida Agenda 11:30 a.m. 11:45 a.m. Welcome and Introduction Eric S. Kastango, B.S.Pharm., M.B.A., FASHP 11:45 a.m. 12:00 p.m. Overview of the Problem of Surface Contamination Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP 12:00 p.m. 12:25 p.m. Monitoring Surface Contamination with Hazardous Drugs: Practical Tools for Measurement Christopher R. Fortier, Pharm.D., FASHP 12:25 p.m. 12:50 p.m. Creating a Culture of Safety: Best Practices in Cleaning and Deactivating Contaminated Surfaces Eric S. Kastango, B.S.Pharm., M.B.A., FASHP Provided by ASHP Supported by an educational grant from BD 12:50 p.m. 1:00 p.m. Faculty Discussion and Audience Questions www.ashpadvantage.com/go/contamination

Processes to Address Surface Contamination Eric S. Kastango, B.S.Pharm., M.B.A., FASHP President and CEO Clinical IQ, LLC and CriticalPoint, LLC Christopher R. Fortier, Pharm.D., FASHP Chief Pharmacy Officer Massachusetts General Hospital Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions Provided by ASHP Supported by an educational grant from BD 1.5 hr Disclosures In accordance with ACCME and ACPE Standards for Commercial Support, ASHP policy requires that all faculty, planners, reviewers, staff, and others in a position to control the content of this presentation disclose their relevant financial relationships. In this activity, only the individuals below have disclosed a relevant financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships. Eric S. Kastango, B.S.Pharm, M.B.A., FASHP CriticalPoint, LLC: stockholder/ownership interest Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP Cardinal Health: employee CriticalPoint, LLC: consultant, speaker Please be advised that this activity is being audio and/or video recorded for archival purposes and, in some cases, for repurposing of the content for enduring materials. 1

Learning Objectives Identify potential sources of surface contamination from hazardous drugs. Describe current and emerging tools for detecting and eliminating hazardous drug contamination. Review essential steps in the cleaning of contaminated surfaces, including the purpose of each one. Develop a plan for implementing an effective program for monitoring and cleaning contaminated surfaces. Introduction Eric S. Kastango, B.S.Pharm, M.B.A., FASHP President and CEO Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey 2

Related affiliation Member of USP Hazardous Drug Expert Panel but this talk is not affiliated with or endorsed by USP There is wide agreement about the best agent to use to deactivate HDs. a. True b. False HD = hazardous drug 3

2017 Compliance Study Facts USP Chapter <800> Compliance Survey tool created and made available by CriticalPoint, LLC in March 2016 for users to conduct a hazardous drug handling self assessment audit of their operations www.800gaptool.com FREE TOOL AVAILABLE Users received a customized and site specific action plan for remediation 1,057 locations registered to participate in one or both compliance studies 2017 Compliance Study Facts As in previous years, CriticalPoint limited reportable respondents to those who completed at least 90% of the questions they were required to answer (respondents are presented with differing items based on their responses to demographic, general compounding, and other non scorable items) Respondents at 662 locations provided information for at least 90% of the required items (roughly 50% less participation than in 2016 when 1185 surveys with at least 90% of required items were completed) Respondents at 187 locations preferred to limit their participation to the USP Chapter <800> Gap Analysis 4

Copyright 2008 2018 CriticalPoint, LLC All rights reserved Hospital Use of CSTDs During Compounding (n=379) Based on observations in the field and testimonials during hazardous drug compounding training, most compounders do not perform negative pressure compounding correctly. Manual negative pressure compounding takes 4 5 times longer (to do it correctly) than it does using any CSTDs. For those reasons, CriticalPoint strongly favors the use of CSTDs during compounding in addition to during administration. CSTDs = closed system transfer devices 5

Non Hospital Use of CSTDs During Compounding (n=78) Environmental Wipe Sampling Performed 454 hospitals reporting 95 non hospitals reporting 6

Frequency of Wipe Sampling 59 hospitals reporting 10 non hospitals reporting CriticalPoint suggests sampling before containment strategy and work practice improvements are made as a baseline. Decontaminate all areas. Sample again after full implementation of containment strategies and work practices. Locations of HD Wipe Sampling 59 hospitals reporting 9 non hospitals reporting Since this testing costs about $2500 for 6 samples, CriticalPoint suggests samples occur outside of the C PECs and C SECs which are contaminated and concentrate on validating effectiveness of containment strategies by sampling of the floor in the anteroom or directly outside the C SCA, sampling in receiving locations, transport vehicles, and patient care areas. C PEC = Containment Primary Engineering Control C SEC = Containment Secondary Engineering Control C SCA = Containment Segregated Compounding Area 7

Results of HD Wipe Sampling Used to Develop or Revise SOPs 59 hospitals reporting 10 non hospitals reporting SOPs = standard operating procedures Repeat Wipe Sampling Performed to Measure Effectiveness of Changes in Work Practice or Facility as a Result of Sampling 49 hospitals reporting Why perform wipe sampling, if you aren t going to do anything with the data? 9 non hospitals reporting 8

Gloves tested to ASTM standard 6978 are worn for handling all HDs including non antineoplastics and reproductive risk only HDs 454 hospitals reporting It seems many people don t see these as dangerous to the worker, but many HDs are and studies prove it! 94 non hospitals reporting Overview of the Problem of Surface Contamination Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions Wilkes Barre, Pennsylvania 9

Related affiliations Member of USP Compounding Expert Committee but this talk is not affiliated with or endorsed by USP Author of The Chapter <800> Answer Book, and Assuring Continuous Compliance with Joint Commission Standards, 8th Edition What contamination concerns you? a. Chemotherapy b. Hormones c. Other hazardous drugs d. None this is not concerning to me 10

Does your organization perform wipe sampling to detect HD contamination? a. Yes, all below detectable levels b. Yes, some results with detectable levels c. No, but considering doing this d. No, discussed but determined not worth doing e. We have not discussed this Measuring Hazards in Healthcare Radiology: badges to detect radioactivity Sterile compounding: air and surface samples to detect microbial contamination Hazardous drugs Medical surveillance for personnel Wipe sampling for surfaces 11

How Do Surfaces Get Contaminated? Packages arrive with external contamination Touch contamination Ineffective procedures Inadequate personal protective equipment (PPE) Spills Visible surface contamination Witnessed spills Taste Hope Subjective Methods Photo credit Patricia C. Kienle. 12

We Need to Move the Needle Subjective Objective Hazardous Drugs Any drug identified by at least one of the following criteria Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity in humans Organ toxicity at low dose in humans or animals Genotoxicity New drugs that mimic existing HDs in structure or toxicity USP General Chapter <800> Hazardous Drugs Handling in Healthcare Settings, USP 39 S1. 13

What Gets Your Attention? Known human carcinogen Reproductive issues Chromosomal damages American Cancer Society. https://www.cancer.org/cancer/cancer causes/general info/known and probablehuman carcinogens.html (accessed 5 Nov 2017). Studies 1999: 75% of pharmacies and 65% of infusion areas had measurable amounts of cyclophosphamide, ifosfamide, and fluorouracil 2010: 75% of pharmacies and 43% of infusion areas had measurable amounts of the above drugs and paclitaxel and cytarabine Connor TH et al. Am J Health Syst Pharm. 1999; 56:1427 32. Connor TH et al. J Occup Environ Med. 2010; 52:1019 1027. 14

Studies 2009 2010: National Institute for Occupational Safety and Health (NIOSH) Health Hazard Evaluation at an oncology clinic 2017: Meta analysis of 39 published studies confirmed a significant association between occupational exposure during the course of a normal workday and increases in chromosomal aberration in healthcare workers Couch J et al. https://www.cdc.gov/niosh/hhe/reports/pdfs/2009 0148 3158.pdf (accessed 5 Nov 2017). Roussel C et al. Mutat Res Rev Mutat Res. In press, online 24 Aug 2017. http://dx.doi.org/10.1016/j.mrrev.2017.08.002 (accessed 5 Nov 2017). Implement containment and work practices Identify surfaces where hazardous drugs have escaped containment Decontaminate Maintain vigilance Action Plan 15

Action Plan Detect Identify Remediate What will you do as a follow up to today s program? (Select all that apply) a. Comply with USP <800> engineering controls b. Comply with USP <800> work practices c. Perform baseline wipe sampling d. Perform wipe sampling every six months 16

Key Takeaways Comply with USP <800> Containment strategies and work practices in <800> support personnel safety Evaluate wipe sampling strategies Baseline and periodic wipe sampling provide sitespecific details Monitoring Surface Contamination with Hazardous Drugs: Practical Tools for Measurement Christopher R. Fortier, Pharm.D., FASHP Chief Pharmacy Officer Massachusetts General Hospital Boston, Massachusetts 17

What is the USP <800> recommended minimum frequency for conducting environmental wipe sampling for HD surfaces? a. Weekly b. Monthly c. Quarterly d. Semi annually e. Annually MGH Background MASSACHUSETTS GENERAL HOSPITAL 18

Massachusetts General Established in 1811 1,000 bed academic medical center In 2017 ranked #4 in the nation on the U.S. News & World Report Best Hospitals List Largest teaching hospital of Harvard Medical School Conducts the largest hospitalbased research program in the country MGH Pharmacy Areas Inpatient Gray Main Inpatient Pharmacy Jackson Compounding Pharmacy Oncology Lunder Inpatient Oncology Satellite Yawkey Ambulatory Oncology Infusion Danvers Ambulatory Oncology Infusion MGH Waltham Ambulatory Oncology Infusion Outpatient Wang Outpatient Pharmacy Revere Outpatient Pharmacy MGH West Outpatient Pharmacy Clinical trials Gray Clinical Trials Pharmacy Yawkey Oncology Clinical Trials Pharmacy Operating room Main campus MGH Waltham Danvers 19

HAZARDOUS DRUG WIPE SAMPLING USP 800 HD Wipe Sampling Guidelines From Section 6. ENVIRONMENTAL QUALITY AND CONTROL Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment) Surface wipe sampling should include Interior of the C PEC and equipment contained in it Pass through chambers Surfaces in staging or work areas near the C PEC Areas adjacent to C PECs (e.g., floors directly under C PEC, staging, and dispensing area) Areas immediately outside the HD buffer room or the C SCA Patient administration areas Currently there are no certifying agencies for vendors of wipe sample kits Currently there is no standard for acceptable limits for HD surface contamination USP General Chapter <800> Hazardous Drugs. Reprinted from USP 40 S2; 2017:5 6. 20

Processes to Address Surface Contamination Current Sampling Methods Photo credit Fred Massoomi, used with permission. Massoomi F et al. Pharm Purch Prod. 2013; 10(7):42. Wipe Analysis Products Focused on Hazardous Drugs Only ChemoGLO Exposure Control B.V. % In use Time to Results Drug Library Cost/drug 36% 4 6 weeks 13 $75/drug 3% 6 8 weeks 7 $75/drug The State of Pharmacy Compounding. Pharm Purch Prod. 2016; 13(suppl 4):S35. 21

What We Learned Lack of Awareness of Test Services Lack of Regulations and Enforcement Cost Time to Results Very little advertising Limited sales force Although USP recommends semi annual testing, the recommendation not enforced Current tests cost $75 $350 per drug/surface plus $50 for shipping 4 6 weeks until written report is available No guidance available for acceptable threshold MGH PROJECT PLAN 22

Considerations in HD Wipe Sampling Frequency Locations Types of drugs Number of drugs Time/day to conduct sampling Shipping requirements Spill management Standard operating procedures (SOPs) Staff training Documentation methods Impact of results Baseline Retesting Financial impact Location IV hoods Floor (ante and buffer rooms) Transport (pass through/cart) Pharmacist checking area Storage area Pharmacist workstation Pharmacy receiving area Nursing medication room Nursing workstation Disposal bin (unit/clinic) Frequency Quarterly HD Wipe Sampling Plan Drugs (based on volume and toxicity) Methotrexate 5 Fluorouracil Cyclophosphamide Doxorubicin Paclitaxel Timing End of day before decontamination during early/middle part of week Perform single session without interruptions Personnel Trained 2 pharmacy technicians Documentation Time/date Person taking the sample Location, sample area size, surface material Sample ID number 23

HD Wipe Sampling Results Identifying the source Redesign workflow Ensure proper personal protective equipment Provide additional staff training on cleaning procedures Establish additional decontamination procedures Potential Sampling Locations Pharmacy Work surface of biological safety cabinet (BSC) Airfoil of BSC Work surface of compounding aseptic contamination isolator (CACI) Floor in front of BSC or CACI Floor in pharmacy Pass through of isolator and/or pharmacy Countertops Equipment Drug storage trays Surface of drug vials Door handles, doorknobs, other high touch areas Computer keyboard/mouse Connor TH et al. In Mansur J, ed. Improving safe handling practices for HDs. Oak Brook, IL: Joint Commission Resources. 2016 Jun; 143. 24

Potential Sampling Locations Patient Care Areas Nurses station where drugs are delivered Storage area of IV bags Countertops Furniture in patient care rooms Infusion pumps Door handles, doorknobs, other high touch areas Computer keyboard/mouse Floor in patient room Floor in patient room Connor TH et al. In Mansur J, ed. Improving safe handling practices for HDs. Oak Brook, IL: Joint Commission Resources. 2016 Jun; 143. Challenges in HD Wipe Sampling No best practices or standards Complicated process Delay before receiving results Uncertainty about what to you do with the data Difficulty identifying the source(s) of contamination Financial impact 25

Next Steps Ongoing assessment and optimization Revise SOPs Consider additional locations and drugs Staff re education Hire a Coordinator for Sterile Compounding Compliance Point of care test and real time results Key Takeaways HD wipe sampling will be required at least semiannually by USP chapter <800> Pharmacies should start now to determine the frequency, locations, and drugs for which wipe sampling is needed Plans should be devised for making use of test results, with ongoing assessment and modification to the wipe sampling program as needed 26

Creating a Culture of Safety: Best Practices in Cleaning and Deactivating Contaminated Surfaces Eric S. Kastango, B.S.Pharm, M.B.A., FASHP, Activity Chair President and CEO Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey According to USP <800>, surface underneath deck of C PEC (BSC or CACI) must be decontaminated, cleaned, and disinfected every a. Day b. Week c. Month d. Year 27

Cleaning Mechanical process (scrubbing) using soap Cleaning or detergent and water to remove dirt, debris and many germs. It also removes invisible debris that interferes with disinfection. Definitions Sanitizing Sanitizing Chemical process of reducing the number of disease causing germs on cleaned surfaces to a safe level. Disinfecting Chemical process that uses specific products Disinfecting to destroy 100% harmful bacteria, viruses and fungi but not necessarily their spores on environmental surfaces. Sporicidal Agents Sporicidal Chemical process that destroys 100% of harmful microorganisms and spores Deactivation Deactivation Render a drug inert or inactive; no single agent identified for all HDs and some HDs have no agent that inactivates Decontamination Decontamination Move a hazardous drug residue (whether active or inactive) from a permanent surface to the surface of a wetted wipe for disposal Definitions Cleaning Removing organic and inorganic materials with a germicidal detergent (or Cleaning sporicidal agent) and sterile water Disinfection Disinfection Destroy microorganisms with sterile 70% IPA or other EPA registered sterile disinfectant 28

Use Decontamination for Deactivation/Decontamination No single agent can deactivate all HDs Since deactivation is not always possible, for the sake of keeping things simple, we use the term decontamination Decontamination is the use of physical and chemical means to render a surface or item safe for handling, use, or disposal 1 So when the term decontamination is used in this context it means both Deactivation (if possible and practical) Decontamination (transferring the agent from a nondisposable surface to a disposable surface) 1 Roberts S et al. J Oncol Pharm Pract. 2006; 12:95. http://opp.sagepub.com/content/12/2/95 (accessed 5 Nov 2017). USP Chapter <800>: Presents 4 steps Deactivation Decontamination Cleaning Disinfection USP Chapter <800> Hazardous Drugs Handling in Healthcare Settings. 29

Framework for Effectiveness 1. Select types of agents for decontamination, cleaning, and disinfection 2. Develop specific procedures for the use of the agents 3. Train personnel who perform decontamination and cleaning 4. Monitor for compliance with PnP and effectiveness of containment PnP = policies and procedures Factors in Selecting Agents Specific chemicals deactivate some HDs check Safety Data Sheet (SDS) Most HDs are water soluble, so using a cleaning agent that has a surfactant allows the HD to be transferred from the contaminated surface to the moist wipe Some agents may act in more than one way Decontamination and sporicidal agent Cleaning and disinfection agent 30

Factors in Selecting Agents for Decontamination Solutions reportedly effective with HDs Appropriate EPA registered oxidizing agents, such as 2% sodium hypochlorite (must be mixed daily) (stronger concentration than when used as a sporicidal) Products containing 80% 10mM sodium lauryl sulfate (SLS) and 20% isopropyl alcohol Peracetic acid and hydrogen peroxide Hydrogen peroxide at a variety of concentrations EPA = Environmental Protection Agency Factors in Selecting Agents for Decontamination Products promoted for HD decontamination should have documented effectiveness in decontaminating surfaces Pay attention to product expiration dates Determine whether products are registered with EPA as disinfectants Cleaning products that are not registered as EPA disinfectants should not be Considered disinfectants Used in place of disinfectants Used as a decontamination and cleaning or sporicidal agent 31

Hydrogen Peroxide Agents Cleaning Agent Classes No residues, no rinsing, not corrosive Effective against yeast, fungi, bacteria, viruses, and spores based on concentration Easy to store and stable Peracetic Acid and Hydrogen Peroxide Agents Broad spectrum; sporicidal at low concentrations and ambient temperatures Inactivates gram positive, gram negative, fungi, yeasts, viruses, and spores Enhances HD removal without inactivation; Byproducts: oxygen, acetic acid, and water Phenolic Agents Many of these also EPA registered disinfectants on environmental surfaces Depending on dilution may be fungicidal, virucidal, and bactericidal Unpleasant odor; leave gummy residue that requires rinsing; may damage surfaces Quaternary Ammonium Compounds Never sporicidal; poor activity against mycobacterium; poor activity against hydrophilic viruses Surfaces must be rinsed; may be irritating to eyes Efficacy reduced by hard water and organic material Develop PnPs PnPs (or SOPs) must be written with enough detail so that a hearing impaired person could follow them (meaning no oral enhancement) Forms (whether electronic or paper) must be sufficiently detailed for reviewer to see what solutions were used, where, and how 32

Follow Manufacturer Instructions for Use How to mix if not ready to use (RTU) Compatibility with Surfaces Low linting wipes Other cleaning agents Example of compatibility information from common agents used in hospital pharmacies Dwell Time (Contact Time) Time that the agent must remain wet on the surface for the agent to have its intended effect Warning: Under wetting of lowlint wipes resulting in insufficient contact time is a common mistake that decreases efficacy 33

Keys to Proper Cleaning Work from cleanest to dirtiest and top to bottom Use unidirectional wipes rather than circular motions Provide slight overlap in motions Replace wipes or rewet mop often Agent dwell time is critical Be aware of the impact of all activities, including cleaning, on the cleanroom environment Photo credit CriticalPoint, LLC. Decontamination, Cleaning, and Disinfection Required by Chapter <800> Hospital Domain Rank 2 of 14 with 75% self reported, overall domain compliance Question Responses Compliance Established written procedures for deactivation/decontamination, cleaning and disinfection which includes at least the following: procedures; agents used; dilutions (if agents are not ready to use); frequency; documentation requirements 810 61% Since you indicated your location does compound/dispense nonsterile HD dosage forms, are cleaning activities in the nonsterile compounding area compliant with the requirements of USP Chapter <795>? 318 75% Since you indicated your location does compound/dispense sterile HD dosage forms, are cleaning activities in the sterile compounding area compliant with the requirements of USP Chapter <797>? 688 91% All persons who perform deactivation/decontamination, cleaning and disinfection activities have received training (which is documented) in all of the following: how to protect themselves and the environment from HD contamination 808 50% The location has chosen agents for deactivation/decontamination, cleaning and disinfection based on the type of contaminant, the location of the target surface and the type of surface materials. Agents selected are compatible with each other and compatible with the target 810 75% surfaces The location disposes of contaminated disposable materials generated by these cleaning activities according to EPA regulations and written policy of the location. 808 85% The location removes residue from deactivation of HDs (especially if agents are used that can be corrosive to stainless steel) with any one of these agents: sodium thiosulfate, sterile water, sterile alcohol, germicidal detergent, or sporicidal agent 808 85% Decontamination occurs by deactivating HD residue OR by physically removing active or inactive HD residue from non-disposable surfaces by transferring it to disposable surfaces (such as wipes). Agents used by the location to decontaminate surfaces of items (vial) do not alter 807 82% the product label. The work surface (also called the deck) of the C-PEC is decontaminated at least as follows: between preparation of different HDs, at least daily when used; any time a spill occurs; before and after certification; anytime the C-PEC is turned off; if the C-PEC is moved 808 70% The area under the work trays of any C-PECs are deactivated/decontaminated, cleaned and disinfected at least monthly. 805 59% This location performs cleaning activities only when compounding activities are not occurring anywhere in the C-SEC. 807 87% This location performs disinfection to areas intended to be sterile (such as the inside of ISO Class 5 areas) after the area has undergone decontamination and cleaning. 686 90% CriticalPoint, LLC. USP Chapter <800> Compliance Survey. 2017. 34

Key Takeaways In addition to performing daily cleaning and disinfection of controlled environments where HDs are compounded, staff must be focused on decontamination and containment strategies as well Staff must receive training in HD hand hygiene and garbing (donning and doffing) Decontamination, cleaning, and disinfection procedures Clear and detailed policies must be written with supporting documentation It is strongly suggested that HD environmental sampling is performed before and after cleaning and disinfection procedures are changed to assess effectiveness Selected References Bohlandt A, Groeneveld S, Fischer E, Schierl R. Cleaning efficiencies of three cleaning agents on four different surfaces after contamination by gemcitabine and 5 fluorouracile. J Occup Environ Health. 2015; 12:384 92. Chu WC, Hon C Y, Danyluk Q et al. Pilot assessment of the antineoplastic drug contamination levels in British Columbian hospitals pre and post cleaning. J Oncol Pharm Pract. 2012; 18:46 51. Connor TH, Massoomi F. Environmental monitoring and medical surveillance of health care workers who handle hazardous drugs (HDs). In Mansur J, ed. Improving safe handling practices for hazardous drugs. Oak Brook, IL: Joint Commission Resources. 2016 Jun; 143. Connor TH, Sessink JM, Harrison BR et al. Surface contamination of chemotherapy drug vials and evaluation of new vial cleaning techniques: results of three studies. Am J Health Syst Pharm. 2005; 62:475 84. Massoomi F, Knolla KL. Identifying hazardous drug residue via wipe analysis. Pharm Purch Prod. 2013; 10(7):42. 35

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About the Faculty Eric S. Kastango, B.S.Pharm., M.B.A., FASHP, Activity Chair President and CEO Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey Eric S. Kastango, B.S.Pharm, M.B.A., FASHP, is President and CEO of Clinical IQ, LLC, a healthcare consulting firm, and CriticalPoint, LLC, a web-based education company. Mr. Kastango received his Bachelor of Science degree in pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and his Master of Business Administration degree from the University of Phoenix. He is also the 2014 recipient of the NABP Henry Cade Memorial Award that recognized the efforts and assistance to the states and NABP to address the compounding tragedy that occurred in 2012. Since 1980, Mr. Kastango has practiced pharmacy in a number of practice settings, including hospitals, community, home care, and industry. He is an active member and Fellow of ASHP. He was elected to the Council of Experts-USP Sterile Compounding Committee for 2005-2010 and 2010-2015 cycles, serving until April 2013. In May 2013, USP recognized Mr. Kastango and the members of the Compounding Expert Committee with an Award for Outstanding Contribution to the USP Standards-Setting Process. He has served on the USP Hazardous Drug Expert Panel since 2010. He is actively working with NABP and state boards of pharmacy to provide training to sterile compounding inspectors. Mr. Kastango is author of several ASHP resources on USP Chapter <797>. He also authored the CriticalPoint web-based educational series on Sterile Compounding and Annual National USP <797> Compliance Survey now in its sixth year. He served on an expert panel for the ASHP Foundation that developed tools for assessing vendors for outsourcing sterile products preparation and readiness for insourcing sterile compounding services. He has over 200 invited national and international presentations on pharmacy practice topics, such as pharmacy compounding and quality systems. Christopher R. Fortier, Pharm.D., FASHP Chief Pharmacy Officer Massachusetts General Hospital Department of Pharmacy Boston, Massachusetts Christopher R. Fortier, Pharm.D., FASHP, is Chief Pharmacy Officer at Massachusetts General Hospital in Boston. In addition, he serves as Adjunct Associate Professor at the University of Connecticut School of Pharmacy, Northeastern University School of Pharmacy, and Massachusetts College of Pharmacy. Dr. Fortier received his Doctor of Pharmacy degree from the University of Connecticut in 2003 and completed both a PGY1 practice residency and a PGY2 health-system pharmacy administration residency at the Medical University of South Carolina Medical Center, where he later served as Manager of Pharmacy for Support and Operating Room Services. In 2013 Dr. Fortier was recognized as a Fellow of ASHP and received the Tradition of Excellence Award from the University of Connecticut Alumni Association. Additionally, in 2008 he received the ASHP New Practitioner Forum s Distinguished Service Award.In 2010, Dr. Fortier was selected to represent South Carolina as a voting member at the ASHP/ASHP Foundation s Pharmacy Practice Model Initiative Summit. He currently is Vice-chair of the ASHP Council on Public Policy and Chair of the ASHP Section of Pharmacy Practice Managers Education Steering Committee. Previously, he served on the ASHP New Practitioners Forum Executive Committee and ASHP Task Force on Organizational Structure, and he was an associate faculty member for the ASHP Foundation s Pharmacy Leadership Academy. In addition, Dr. Fortier served 8 years on the Vizient AMC Pharmacy Network (formally University HealthSystem Consortium) Executive Committee and chaired the Medication Use Informatics and Technology Committee. Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions Wilkes-Barre, Pennsylvania Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP, is Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions. She received her pharmacy degree from Philadelphia College of Pharmacy and Science, and a Master in Public Administration degree from Marywood University in Scranton, Penn. She completed the Executive Fellowship in Patient Safety from Virginia Commonwealth University and is Adjunct Associate Professor at Wilkes University in Wilkes-Barre, Penn. Ms. Kienle has served on the Board of Directors of ASHP and as President of the Pennsylvania Society of Health-System Pharmacists (PSHP). She is a Fellow of ASHP and was named Pharmacist of the Year by PSHP. She received the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management and the Distinguished Leadership Award from ASHP. She has served on the Pharmacotherapy Specialty Council of the Board of Pharmaceutical Specialties, Pennsylvania Patient Safety Authority, Hospital Professional and Technical Advisory Committee of The Joint Commission, and Board of Governors of the National Patient Safety Foundation. She is a current member of the USP Compounding Expert Committee and chair of the Subcommittee on Hazardous Drugs. Ms. Kienle is the author of Compounding Sterile Preparations: ASHP s Visual Guide to Chapter <797> Companion Guide and video, co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, 8th edition, and author of The Chapter <800> Answer Book. She edited Understanding JCAHO Requirements for Hospital Pharmacies. She is a frequent presenter to professional groups with special interests in promoting medication safety, compounding sterile preparations, accreditation, and regulatory issues. Cover photo credit CriticalPoint, LLC On-demand activity of today s live symposium coming in March 2018 Accreditation www.ashpadvantage.com/go/contamination The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. n ACPE #: 0204-0000-17-446-L07-P n ACPE #: 0204-0000-17-446-L07-T n 1.5 contact hours, application-based n Qualifies for compounding CPE