surface contamination · patricia c. kienle, b.s.pharm., m.p.a., fashp director, accreditation and...
TRANSCRIPT
www.ashpadvantage.com/go/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 IntroductionEric S. Kastango, B.S.Pharm., M.B.A., FASHP
11:45 a.m. – 12:00 p.m.Overview of the Problem of Surface ContaminationPatricia 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 MeasurementChristopher 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 SurfacesEric S. Kastango, B.S.Pharm., M.B.A., FASHP
12:50 p.m. – 1:00 p.m.Faculty Discussion and Audience Questions
Provided by ASHP
Supported by an educational grant from BD
Processes to Address
For USP Chapter <800>
Surface Contamination
Processes to Address Surface ContaminationFor USP Chapter <800>
Processes to Address Surface Contamination For USP Chapter <800>
Provided by ASHP Supported by an educational grant from BD
Eric S. Kastango, B.S.Pharm., M.B.A., FASHPPresident and CEO
Clinical IQ, LLC and CriticalPoint, LLC
Christopher R. Fortier, Pharm.D., FASHPChief Pharmacy Officer
Massachusetts General Hospital
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHPDirector, Accreditation and Medication SafetyCardinal Health Innovative Delivery Solutions
1.5 hr
DisclosuresIn 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.
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Processes to Address Surface ContaminationFor USP Chapter <800>
• 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.
Learning Objectives
Introduction
Eric S. Kastango, B.S.Pharm, M.B.A., FASHP
President and CEO
Clinical IQ, LLC and CriticalPoint, LLC
Madison, New Jersey
Copyright © 2017 American Society of Health-System Pharmacists, Inc. All rights reserved.
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
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Processes to Address Surface ContaminationFor USP Chapter <800>
Non‐Hospital Use of CSTDs During Compounding (n=78)
Environmental Wipe Sampling Performed
454 hospitals reporting
95 non‐hospitals reporting
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 ControlC‐SEC = Containment Secondary Engineering ControlC‐SCA = Containment Segregated Compounding Area
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
9 non‐hospitals reporting
49 hospitals reporting
Why perform wipe sampling,if you aren’t going to do anything with the data?
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Processes to Address Surface ContaminationFor USP Chapter <800>
Gloves tested to ASTM standard 6978 are worn for handling all HDs including non‐antineoplastics and reproductive risk only HDs
94 non‐hospitals reporting
454 hospitals reporting
It seems many people don’t see these as dangerous to the worker, but many HDs are and studies prove it!
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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 drugsd. None – this is not concerning to me
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Processes to Address Surface ContaminationFor USP Chapter <800>
Does your organization perform wipe sampling to detect HD contamination?
a. Yes, all below detectable levelsb. Yes, some results with detectable levelsc. No, but considering doing thisd. No, discussed but determined not worth doinge. We have not discussed this
• 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
Measuring Hazards in Healthcare
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Processes to Address Surface ContaminationFor USP Chapter <800>
How Do Surfaces Get Contaminated?• Packages arrive with external contamination
• Touch contamination
• Ineffective procedures• Inadequate personal protective equipment (PPE)
• Spills
Subjective Methods• Visible surface contamination
• Witnessed spills
• Taste
• Hope
Photo credit Patricia C. Kienle.
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Processes to Address Surface ContaminationFor USP Chapter <800>
We Need to Move the Needle
Subjective Objective
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.
Hazardous Drugs
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Processes to Address Surface ContaminationFor USP Chapter <800>
• Known human carcinogen• Reproductive issues• Chromosomal damages
American Cancer Society. https://www.cancer.org/cancer/cancer‐causes/general‐info/known‐and‐probable‐human‐carcinogens.html (accessed 5 Nov 2017).
What Gets Your Attention?
• 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.
Studies …
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Processes to Address Surface ContaminationFor USP Chapter <800>
• 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).
… Studies
• Implement containment and work practices• Identify surfaces where hazardous drugs have escaped containment
• Decontaminate • Maintain vigilance
Action Plan
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 controlsb. Comply with USP <800> work practicesc. Perform baseline wipe sampling
d. Perform wipe sampling every six months
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 site‐specific 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
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Processes to Address Surface ContaminationFor USP Chapter <800>
What is the USP <800> recommended minimum frequency for conducting environmental wipe sampling for HD surfaces?
a. Weekly b. Monthly
c. Quarterly
d. Semi‐annuallye. Annually
MGH Background
MASSACHUSETTSGENERALHOSPITAL
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 hospital‐based 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
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Processes to Address Surface ContaminationFor USP Chapter <800>
HAZARDOUS DRUG WIPE SAMPLING
USP 800 HD Wipe Sampling GuidelinesFrom 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.
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Processes to Address Surface ContaminationFor USP Chapter <800>
Current Sampling Methods
Photo credit Fred Massoomi, used with permission.Massoomi F et al. Pharm Purch Prod. 2013; 10(7):42.
Wipe Analysis Products
% In use
Time to Results
Drug Library
Cost/drug
Focused on HazardousDrugs Only
ChemoGLO36% 4‐6 weeks 13 $75/drug
Exposure Control B.V. 3% 6‐8 weeks 7 $75/drug
The State of Pharmacy Compounding. Pharm Purch Prod. 2016; 13(suppl 4):S35.
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Processes to Address Surface ContaminationFor USP Chapter <800>
What We LearnedLack of
Awareness of Test Services
Lack of Regulations and Enforcement
Cost Time to Results
•Although USP recommends semi‐annual testing, the recommendation not enforced
•No guidance available for “acceptable” threshold
•Current tests cost $75‐$350 per drug/surface plus $50 for shipping
•Very little advertising
• Limited sales force
•4‐6 weeks until written report is available
MGH PROJECT PLAN
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
HD Wipe Sampling Plan• 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
• 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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 traysSurface 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.
Copyright © 2017 American Society of Health-System Pharmacists, Inc. All rights reserved.
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 semi‐annually 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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
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Processes to Address Surface ContaminationFor USP Chapter <800>
DisinfectingChemical process that uses specific products to destroy 100% harmful bacteria, viruses and fungi but not
necessarily their spores on environmental surfaces.
Disinfecting
Sporicidal AgentsChemical process that destroys 100% of harmful microorganisms
and spores
SanitizingChemical process of reducing the number of disease‐causing germs on cleaned surfaces to a safe level.
CleaningMechanical process (scrubbing)
using soap or detergent and water to remove dirt, debris and many germs. It also removes invisible debris that interferes with
disinfection.
Sporicidal
SanitizingCleaning
Definitions
CleaningRemoving organic and inorganic materials with a germicidal
detergent (or sporicidal agent) and sterile water
Cleaning
DisinfectionDestroy microorganisms with sterile 70% IPA or other EPA registered
sterile disinfectant
DecontaminationMove a hazardous drug residue (whether active or inactive) from a permanent surface to the surface of a wetted wipe for disposal
DeactivationRender a drug inert or inactive; no single agent identified for all HDs and some HDs have no agent that
inactivates
Disinfection
DecontaminationDeactivation
Definitions
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 disposal1
• 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)1Roberts 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 stepsDeactivation
Decontamination
Cleaning
Disinfection
USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.
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Processes to Address Surface ContaminationFor USP Chapter <800>
Framework for Effectiveness1. 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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
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Processes to Address Surface ContaminationFor USP Chapter <800>
Cleaning Agent ClassesHydrogen Peroxide Agents
•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
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 low‐lint wipes resulting in insufficient contact time is a common mistake that decreases efficacy
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Processes to Address Surface ContaminationFor USP Chapter <800>
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
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 surfaces
810 75%
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 the product label.
807 82%
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%
Question Responses Compliance
CriticalPoint, LLC. USP Chapter <800> Compliance Survey. 2017.
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Processes to Address Surface ContaminationFor USP Chapter <800>
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 PurchProd. 2013; 10(7):42.
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Processes to Address Surface ContaminationFor USP Chapter <800>
ASHP CE Processing Deadline: January 31 elearning.ashp.org Code: ______________ Complete evaluation Additional instructions in
handout
Thank you for Joining Us
Download the handout at www.ashpadvantage.com/go/contamination
On‐demand activity based on today’s live symposium coming March 2018
www.ashpadvantage.com/go/contamination
Copyright © 2017 American Society of Health-System Pharmacists, Inc. All rights reserved.
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Claiming CE Credit 1. Log in to the ASHP eLearning Portal at elearning.ashp.org with the
email address and password that you used when registering for the Midyear.The system validates your meeting registration to grant you access to claim credit.
2. Click on Process CE for the Midyear Clinical Meeting and Exhibition.3. Enter the Attendance Codes that were announced during the sessions and click Submit.4. Click Claim for any session.5. Complete the Evaluation.6. Once all requirements are complete, click Claim Credit for the appropriate profession.
Pharmacists and Pharmacy Technicians: Be prepared to provide your NABP eProfile ID, birthmonth and date (required in order for ASHP to submit your credits to CPE Monitor).Others (International, students, etc.). Select ASHP Statement of Completion.
All continuing pharmacy education credits must be claimed within 60 days of the live session you attend. To be sure your CE is accepted inside of ACPE's 60-day
window, plan to process your CE before January 31, 2018!
Exhibitors Exhibitors should complete the steps below first. If you encounter any issues with the process, please stop by the Meeting Info Desk onsite or email [email protected].
1. Log in to www.ashp.org/ExhibitorCE with your ASHP username and password.2. Click on the Get Started button.3. Select the 2017 Midyear Clinical Meeting and Exhibition from the dropdown menu.4. Select your Exhibiting Company from the list of exhibitors. Your screen will change and you will
then be logged into the ASHP eLearning Portal.5. Follow the instructions in the section above this, starting with Step Two.
For Offsite Webinar Attendees 1. Log in to the ASHP eLearning Portal at elearning.ashp.org/my-activities. If you have never
registered with ASHP, use the Register link to set up a free account.2. Enter the Enrollment Code announced during the webinar in the Enrollment Code box and click
Redeem. The title of this activity will appear in a pop-up box on your screen. Click on Go or theactivity title.
3. Complete all required elements. Go to Step Six above.
Questions? Contact [email protected]!
About the Faculty
On-demand activity of today’s live symposium coming in March 2018
www.ashpadvantage.com/go/contamination
Accreditation
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHPDirector, Accreditation and Medication SafetyCardinal Health Innovative Delivery SolutionsWilkes-Barre, Pennsylvania
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP, is Director of Accreditation and Medication Safety for Cardinal Health Inno-vative 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 Commis-sion, 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 Assur-ing 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.
Eric S. Kastango, B.S.Pharm., M.B.A., FASHP, Activity ChairPresident and CEOClinical IQ, LLC and CriticalPoint, LLCMadison, 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 Massachu-
setts 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 Commit-tee 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 nation-al and international presentations on pharmacy practice topics, such as pharmacy compounding and quality systems.
Christopher R. Fortier, Pharm.D., FASHPChief Pharmacy OfficerMassachusetts General HospitalDepartment of PharmacyBoston, Massachusetts
Christopher R. Fortier, Pharm.D., FASHP, is Chief Phar-macy Officer at Massachusetts General Hospital in Boston. In addition, he serves as Adjunct Associate Professor at the Uni-versity 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 Prac-titioner Forum’s Distinguished Service Award.In 2010, Dr. Fortier was selected to represent South Carolina as a voting member at the ASHP/ASHP Founda-tion’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.
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-Pn ACPE #: 0204-0000-17-446-L07-Tn 1.5 contact hours, application-basedn Qualifies for compounding CPE
Cover photo credit CriticalPoint, LLC