Strategies for Ensuring Compliance by the December 2019 ... · Update on USP Chapter : Strategies for Ensuring Compliance by the December 2019 Deadline • Member of the

Monday, June 10, 2019Boston, Massachusetts

A Promotional Theater conducted at the 2019 ASHP Summer Meetings and Exhibition

This Promotional Theater is planned by ASHP Advantage and sponsored by Fresenius Kabi

Strategies for Ensuring Compliance by the December 2019 Deadline

www.ashpadvantage.com/uspchanges

USPChapter<797>

UPDATE ON USP CHAPTER <797>

AGENDA6:00 – 6:30 p.m.Buffet Dinner

6:30 – 6:55 p.m.Overview of Changes to USP Chapter <797>Patricia C. Kienle, B.S.Pharm., M.P.A, FASHP

6:55 – 7:20 p.m.Employing Changes to USP Chapter <797>: Is Your Facility Ready?Eric S. Kastango, B.S.Pharm., M.B.A., FASHP

7:20 – 7:45 p.m.Practical Approaches to Attaining Compliance with USP Chapter <797>: One Health System’s ExperienceAshley Duty, Pharm.D., M.S.

7:45 – 8:30 p.m.Strategies for Ensuring Compliance with USP Chapter <797>: Faculty Discussion and Audience Questions All Faculty

Patricia C. Kienle, B.S.Pharm., M.P.A, FASHPDirector, Accreditation and Medication SafetyCardinal Health Innovative Delivery SolutionsWilkes‐Barre, Pennsylvania

Ashley Duty, Pharm.D., M.S.Clinical Pharmacy Operations ManagerChildren’s Mercy Kansas City, Missouri

Eric S. Kastango, B.S.Pharm., M.B.A., FASHPPresident and CEOClinical IQ, LLC and CriticalPoint, LLCMadison, New Jersey

This Promotional Theater is planned by ASHP Advantage and sponsored by Fresenius Kabi

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 financial relationships. In this activity, only the individual below has disclosed a relevant financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.• Eric Kastango

– CriticalPoint, LLC: stockholder/ownership interest– Wolter Kluwer: royalties

• Patricia C. Kienle– Cardinal Health: employee– CriticalPoint, LLC: consultant

Disclosures

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.

Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline

At the conclusion of this activity, participants should be able to• Describe the primary changes to USP Chapter <797> that

will be official on December 1, 2019• Identify best practices for ensuring safety of sterile

products within a health system• Compare current operations with revised USP Chapter

<797> standards• Develop a plan for making changes to attain compliance

with revised USP Chapter <797>

Learning Objectives

Overview of Changes to USP Chapter <797>

Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP

Director, Accreditation and Medication Safety

Cardinal Health Innovative Delivery Solutions

Wilkes‐Barre, Pennsylvania

©2019 American Society of Health-System Pharmacists, Inc. All rights reserved.

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• Member of the USP Compounding Expert Committeeand speaker for USP compounding courses, but this talkis not affiliated with or endorsed by USP

• Author of The Chapter <800> Answer Book and AssuringContinuous Compliance with Joint CommissionStandards, 8th Edition, published by ASHP

Related Affiliations

Figure courtesy of USP.

It’s Been a Long Ride …


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• USP is a standard‐settingorganization

• Regulators incorporatestandards into their regulations

• Accreditation organizationsincorporate best practices intotheir own standards

Image courtesy of USP.

USP General Chapters

Personnel

Facilities

Monitoring

Best Practices Have Evolved

State of control


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• Philosophy– What drives the assignment of the beyond‐use date (BUD)

• Administering is not compounding• Facility design requirements

– How can we create the safest workspace• Beyond‐use dates• Monitoring frequency

– What personnel and facility monitoring can best detectconcerns

What’s Changed?

• Old: components drive the BUD– Sterile or nonsterile?– For a single patient or for many patients?– Complexity of process

• Revised: facility design drives the BUD– Cleanroom suite– Segregated compounding area

Philosophy


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• Responsibility• Development and maintenance of policies andprocedures

• Assuring competence of personnel• Evaluation of certification and environmentalmonitoring

Designated Person

• Core skills– Specific competencies

• Hand hygiene, garbing, aseptic manipulation

– General competencies• Calculations, aseptic technique, use of equipment,materials transfer, cleaning

Written Training Program


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• Didactic• Demonstration of core skills• Three gloved fingertip tests to demonstrateability to aseptically garb

• Media fill test to demonstrate ability toaseptically prepare CSP

Initial Competency Documentation

• Every six months– Media fill test to demonstrate ability to asepticallyprepare CSPs

– One gloved fingertip and thumb sampling todemonstrate ability to maintain asepsis duringcompounding

Competency Documentation


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• Annual demonstration of core skills

Competency Documentation

• Preparation for administration• Administration• Immediate use• Preparation of allergen extracts• Handling radiopharmaceuticals

Special Practices


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• As long as …– For a single patient– Will not be stored

Centers for Disease Control and Prevention. Safe injection practices to prevent transmission of infections to patients. https://www.cdc.gov/injectionsafety/ip07_standardprecaution.html

(accessed 2019 May 20).

Administering is not Compounding

What type of facility do you have? Select all that apply.

a. Cleanroom suite: anteroom + buffer roomb. Combined ante/buffer roomc. Segregated compounding aread. No compliant facility – immediate use preparation

onlye. Don’t know or not at a site that prepares CSPs

CSPs = compounded sterile preparations


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• Ambient air• Segregated compounding area• Cleanroom suite

– Anteroom + buffer room

Facility Design

• Primary engineering control (PEC)– Laminar air flow systems– Compounding isolators– Pharmaceutical isolators

• Secondary engineering control (SEC)– Cleanroom suite– Segregated compounding area

Facilities


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• Type and placement of primary engineering control• Sink placement• Visible lines of demarcation and doffing• HEPA‐filtered ceiling air• Ability to access ceiling• Control of doors• Temperature, humidity, and pressure monitors• Calibration of equipment

Facilities

Processing

• Aseptic– Includes filtration

• Terminal sterilization– Steam– Dry heat– Irradiation

Photo courtesy of CriticalPoint, LLC. Copyright © 2018 CriticalPoint, LLC. All rights reserved.


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• Risk levels eliminated• Allowance for preparation of nonsterile‐to‐sterile compounded sterile preparations (CSPs) with limited BUDs

Assignment of BUDs

Aseptically‐prepared in compliant segregated compounding area (SCA) or containment segregated compounding area (C‐SCA)

Category 1 CSP Maximum BUDs

Room Temperature(20° to 25° C)

Refrigerated(2° to 8° C)

Made from only sterile components 12 hours 24 hours

Made from one or more nonsterile component

12 hours 24 hours


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Aseptically‐prepared in compliant compounding suite, no sterility testing, no additional preservative

Category 2 CSP Maximum BUDs

Room Temperature(20° to 25° C)

Refrigerated(2° to 8° C)

Frozen(‐25° to ‐10° C)

Made from only sterile components 4 days 10 days 45 days

Made from one or more nonsterile component

1 day 4 days 45 days

• Nonviable characteristics– Air flow

• Smoke studies

– HEPA‐filtered ceiling air– Pressure differentials– Temperature– Humidity

Certification


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Have you ever received monitoring test results that exceed action levels?

a. Yes – personnel onlyb. Yes – facilities onlyc. Yes – personnel and facilitiesd. Noe. Don’t know or not at a site that prepares CSPs

Environmental Monitoring

Air Surface


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• Minimum frequency – every 6 months• Action levels

CFU per 1000 liters of air per plate

Volumetric Active Air Sampling

ISO Class Action Levels

5 > 17 > 108 > 100

• Minimum frequency – monthly• Action levels

CFU per plate or swab

Surface Sampling

ISO Class Action Levels

5 > 37 > 58 > 50


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• Policies and procedures• BUDs• Documentation of personnel training• Frequency of personnel monitoring• Frequency of surface sampling• Plan for reaction to out‐of‐specification results

What Might You Have to Change?

Keeping Patients Safe

Personnel

Quality


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• Philosophy for assessing risk in CSP preparationhas evolved from a focus on product‐relatedcomponents to the facility in which the CSP ismixed

• Competency of personnel is key to safe practices• Required frequency of monitoring has increasedto better demonstrate state of control

Key Takeaways

Employing Changes to USP Chapter <797>: Is Your Facility Ready?

Eric S. Kastango, B.S. Pharm., M.B.A., FASHP

President and CEO

Kastango Consulting Group d/b/a Clinical IQ, LLC

CriticalPoint, LLC


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• All images in this presentation are used withpermission from CriticalPoint, LLC. Copyright ©2006‐2019 CriticalPoint, LLC. All rights reserved.

• Use of this educational material by a 3rd partydoes not constitute an endorsement byCriticalPoint, LLC or Clinical IQ, LLC.

Acknowledgments

“By failing to prepare, you are preparing to fail.”

Benjamin Franklin


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Risk Category

Category 1 PEC located in SCA (non classified)

Category 2PEC located in

buffer room served by anteroom

Revised USP Chapter <797> Paradigm

PEC = primary engineering control, SCA = segregated containment area

Primary Engineering Controls

Laminar Air Flow Systems (LAFS)

• Laminar airflow workbenches(LAFWs) or work stations

• Laminar air flow zones• Biological safety cabinets(BSCs)

Restricted Access Barrier System (RABS)

• Compounding aseptic isolator(CAI)

• Compounding asepticcontainment isolator (CACI)

Isolators(Pharmaceutical)

• Transfer ports• Use sporicidal chemical

decontamination• Constant overpressure

requirement


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Facility Requirements

Category 1 = Cleanroom Suite or SCA

Category 2 = Cleanroom Suite

CAI or CACI (now called a Restricted Access Barrier System or RABS) must be placed in cleanroom suite to get BUDs greater than 12 hours room temperature and 24 hours refrigerated!

RABS not treated differently than BSCs or LAFS

Category 1: PEC or C‐PEC inside SCA or C‐SCA

• BUD– 12 hours or less at controlled room

temperature– 24 hours or less when refrigerated

• Only if made in accordance with applicablerequirements for Category 1 CSPs

• Sterility and endotoxin testing neverrequired

C‐PEC = containment primary engineering controlC‐SCA = containment segregated compounding area


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• USP Chapter <797> (2008) allowed CAIs and CACIs(now RABS) with the default BUDs in the chapter– This allowance will no longer be compliant with thestandard on Dec 1, 2019

• All hospitals will be challenged by this new paradigm• Alternative strategies like RTU, proprietary vial‐bagsystems and staffing increases must be evaluated

Impact of Category 1

RTU = ready‐to‐use

• BUD– Greater than 12 hours at controlled

room temperature– Greater than 24 hours when

refrigerated• Sterility and endotoxin testing

based on BUD assigned• Only if made in accordance with

applicable requirements forCategory 2 CSPs

Category 2: PEC or C‐PEC in Buffer Room with Anteroom


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Defining a Cleanroom Suite

• ISO‐classified anteroom with fixed walls and doors• Controls to minimize the flow of lower‐quality air into the

more controlled areas• Supply air introduced through HEPA filters located in the

ceiling• Low wall air returns unless a visual smoke study is

performed• Pressure‐differential monitoring system• Line of demarcation in the anteroom

Defining a Cleanroom Suite


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• Design of the facility should take into account– Number of personnel and their movements– Equipment, supplies, and components for CSP preparation

• Cleanroom suite should– Be at temperature of 20°C or cooler and at a relative humidity

below 60%– Provide comfortable conditions for personnel wearing required garb

• Facility and pass‐through doors– Should be interlocking– Doors that do not interlock MUST never be opened at the same

time

Important “shoulds”

Air Exchanges = Air Changes Per Hour (ACPH)

Compounding Area

ACPH Requirements (HEPA‐filtered supply air)

Pressure Requirements (inches of water

column)

Unclassified SCA None NoneUnclassified C‐SCA ≥12 (exhaust) Negative 0.01 to 0.03ISO Class 7 Non‐HD buffer room ≥30 (supply) Minimum positive 0.02ISO Class 7 HD buffer room ≥30 (supply) Negative 0.01 to 0.03ISO Class 7 anteroom ≥30 (supply) Minimum positive 0.02ISO Class 8 anteroom ≥20 (supply) Minimum positive 0.02


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• Highly controversial part of certification• Chapter <797> only prescribes minimum ACPH based on HEPA‐

filtered supply air except for C‐SCA (based on exhaust)• ACPH often needs to be higher to maintain a state of control• Factors affecting needed ACPH

– Number of personnel in the area– Number of particulates generated from processes in the area– Equipment located in the room– Room air pressure– Temperature

Air Exchanges

Air Change SpecificsISO Class 7 ISO Class 8

• ≥20 ACPH• Clarified because current chapter

does not specify anteroom ACPH– This is from FDA Aseptic Processing

Guidance• All ACPH must be supplied from

the HVAC through HEPA filterslocated in the ceiling

• Certification report mustdocument total ACPH

• ≥30 ACPH• ≥15 ACPH of the total air changes

must come from the HVAC throughHEPA filters located in the ceiling

• If the PEC is used to meet theminimum total ACPHs required, thePEC must not be turned off exceptfor maintenance

• Certification report must include theACPH from HVAC, ACPH contributedfrom the PEC, and the total ACPH


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Air Change SpecificsISO Class 7 ISO Class 8

• ≥20 ACPH• Clarified because current chapter

does not specify anteroom ACPH– This is from FDA Aseptic Processing

Guidance• All ACPH must be supplied from

the HVAC through HEPA filterslocated in the ceiling

• Certification report mustdocument total ACPH

• ≥30 ACPH• ≥15 ACPH of the total air changes

must come from the HVAC through HEPA filters located in the ceiling

• If the PEC is used to meet the minimum total ACPHs required, the PEC must not be turned off except for maintenance

• Certification report must include theACPH from HVAC, ACPH contributedfrom the PEC, and the total ACPH

Compounding area must be certified according to the CETA application guide for Sterile Compounding

Facilities or an equivalent guideline

What things do you have in your anteroom? Select all that apply.

a. Nothingb. Sinkc. Line of demarcationd. Workstation for checking CSPse. Don’t know or not at a site that prepares CSPs


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Sink• Should be hands free• If serving a cleanroom suite, sink

can be inside the anteroom oroutside the anteroom in theadjacent space

• If serving an SCA, then sink mustbe– Accessible– At least 1 meter from the PEC– NOT inside the SCA perimeter

Many requirements apply to ALL CSPs, such as:

Table 1: Summary of Minimum Requirements

• Observation of hand hygieneand garbing every 6 months

• Recertification of PECs every 6months (SECs in Category 2)

• Ongoing gloved fingertipsampling every 6 months

• Nonviable air monitoringevery 6 months

•Media fill testing every 6months

• Viable air sampling every 6months

• 100% visual inspection • Surface sampling MONTHLY


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Personnel Qualifications: Same for Category 1 and Category 2

Requirement Frequency

Visual observation of hand hygiene and garbing Every 6 monthsGloved fingertip and thumb sampling Every 6 monthsMedia fill testing Every 6 monthsRequalification Every 12 months

Training is required every 12 months in appropriate sterile compounding principles and practices

• Training is not just for compounding staff• Needed for other personnel handling CSPs or accessing the compounding area• Must demonstrate competency in proper behavior to maintain the

environment

Other Personnel


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Garbing and Hand Hygiene

• Disposable nail cleaner must be used• Garbing sequence is not specified

– Left up to the facility to decide– Define in standard operating

procedure• Gowns may be re‐used within same

shift if the gown is maintained in aclassified area or SCA

• CAI and CACI– Disposable gloves under isolator gloves– Sterile gloves over isolator gloves

Gloved Fingertip and Thumb Sampling (GFS)

• No changes to the frequency• Clarifies that initial GFS is done after

“separate and complete hand hygieneand full garbing”

• Box 2‐1 in USP Chapter <797> indicatesthat fingers and thumb are rolled overthe surface

• Gives multiple options for devices touse

• Provides incubation parameters thatare longer and require twotemperatures


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• Failure of any of the following will require successfulreevaluation before personnel can resume compounding– Hand hygiene/garbing– Aseptic technique– GFS– Media fill testing

• How will this affect your ability to care for patients if youneed to wait 14 days for media fill results?

Reevaluation, Retraining, Requalification

• The USP Chapter <797> revisions clarified several key facility‐relateddesign and performance elements along with certificationrequirements

• The use of CAI or CACI (RABS) offer no advantage over “open‐front”primary engineering controls or allow for the default BUDs in the USPChapter <797>

• All hospitals will need to reevaluate their strategies for compoundingand dispensing CSPs due to shortened BUDs in facilities with a Category1 operation

• Use and location of HEPA filters in the HVAC system should be accessed

Key Takeaways


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Practical Approaches to Attaining Compliance with USP Chapter <797>:

One Health System’s Experience

Ashley Duty, Pharm.D., M.S.

Clinical Pharmacy Operations Manager

Children’s Mercy

Kansas City, Missouri

• Four cleanrooms with positive and negativecompounding spaces and anterooms

• One cleanroom with only positive compoundingspace and anteroom

• Two segregated compounding areas

Children’s Mercy Sterile Compounding Areas


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• Using prepared gap analysis tools vs. creatingyour own– Time consuming– Customizable

• Status and assignments

Gap Analysis

Example Custom Gap Analysis


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See enlargement, page 45


• You have 100+ line items, where do you start?– Assess what you’ve already achieved– Determine which items require capital andconstruction

– Identify individuals to assist you– Don’t become overwhelmed

Digesting the Gap Analysis Results

Have you completed a gap analysis for USP Chapter <797>?

a. Yesb. In progressc. Nod. N/A


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Policy Writing

Which came first – the policy or the practice change?

• Use policies and standard operating procedures– Flexibility

• Separate policies vs. one large policy

Policy Writing


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Examples

• Policy– Beyond‐use dating– Certification frequencies– Cleaning frequencies– Personnel requirements– Documentationrequirements

• Procedures– Aseptic technique testing– Viable air sampling– RABS cleaning process– Parenteral nutritioncompounder setup

– Repeater pumpcalibration

• Determine the uses for the compounding space– Limited anticipatory compounding

• Workflow impact

– Appropriate SCA placement

Segregated Compounding Areas (SCAs)


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• Operating room SCA– Medications are used within 2‐3 hours– Limited number of medications and manipulations– Access to operating room space is already limitedand laundered scrubs are required

Segregated Compounding Areas

Construction and Design Issues

• Temporary fixes– Anteroom expansion– Interlocking pass‐throughs

– Interlocking doors– New paint

• Complete renovationsor new construction– Consider pharmacyoperations duringconstruction

– New space or currentlocation?


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Photos: Ashley Duty

• Get involved early and know your architects– Ask your pharmacy colleagues who they recommend

• Know where your air comes from and where itgoes after it leaves your cleanroom– Air handlers, ductwork, plenums

• Future thinking

Construction and Design Issues


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• CSP batch/cartfill frequency change– Increased frequency = decreased time betweenpreparation and administration

– Change staffing patterns for preparation and delivery– Potential for decreased waste

Impact of CSP BUD Change

Impact of CSP BUD Change

• Additional productoptions– Premixed solutions– Alternative deliverysystems

– Outsourced options

• Drug shortages– Minimizing waste– Less control over packagesizes


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• Historical practice of using diluted stock bags formultiple patients over a few days– Especially prevalent in pediatrics

• Stock/dilution bags now have a BUD of 12 hours– Reevaluation of vial sizes purchased andconcentrations

Multi‐Patient Stock Bags

Administration BUDs

• Explaining BUDs vs. expiration dates to nursingcolleagues can prove challenging– Standard tubing change times

• Limitations within dose preparation system todifferentiate stability of medication vs. sterility ofthe preparation (BUD)


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• During every 6‐month certification is helpful, but provides only a snapshot

• Challenging to react to positive results involving highly pathogenic organisms and reschedule certification

• Viable air sampling machine can be shared among multiple practice sites for quarterly or monthly testing

Viable Air Sampling

• Positive results– Need to be evaluated by an environmental lab, not a clinical lab

• Responding to a positive sample– Assess who, what, when, where– Work with your hospital's infection prevention and control team

Viable Air Sampling


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• Gravity flow incubators– No long‐term incubation needed– More budget friendly than forced air incubator

• Discuss with and obtain recommendations from laboratory or biomedical engineers

• Two devices (20‐25˚C and 30‐35˚C)– Stackable

Incubators

• Increased from every 12 months to every 6 months– Balance the need for an adequate number of employees competent to prepare CSPs

– Staffing during challenging situations• Recordkeeping

– Paper, spreadsheet, electronic database or form– Web‐based programs

Personnel Competencies and Recordkeeping


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Which of the following types of systems does your health system use for tracking personnel competencies and viable air sampling? Select all that apply.

a. Paper or electronic formsb. Electronic spreadsheetsc. Internal websited. External subscription websitee. N/A or unsure

Online Personnel Recordkeeping

• Advantages– Consistent– Reminders– Customized assignments– Hard to misplace or lose

• Disadvantages– Cost– Need for contracting– Ease of retrieval– Interconnectivity withhuman resourcesrequirements


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• Pharmacy staff cleaning vs. environmentalservices– Competencies– Consistency

• Outsourced terminal cleaning

Terminal Cleaning of Compounding Suite

• A gap analysis is a great way to determine whereyou need to devote time and resources to attainChapter USP <797> compliance

• Construction projects can vary from small to large,but being closely involved and forward thinking isparamount

• Ensure that your personnel training records arecomplete, consistent, and easily retrievable

Key Takeaways


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• USP Compounding Compendium, available from USP at www.usp.org

• USP FAQs at www.usp.org

• ASHP Sterile Compounding Resource Center, available at www.ashp.org

• CriticalPoint Peer Network, available at https://peernetwork.criticalpoint.info

Selected Resources

Strategies for Ensuring Compliance with USP Chapter <797>: Faculty Discussion

Patricia C. Kienle, Activity Chair

Ashley Duty

Eric S. Kastango


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• We want to address the issues and questions most important to YOU!

Exploring the Issues


44

Exam

ple Custom Gap

Analysis

Abbreviations Used in Presentations ACPH air changes per hour

BSC

BUD

CAI

CACI

CDC

CETA

C-PEC

C-SCA

CSP

GFS

HD

HEPA

HVAC

ISO

LAFS

LAFW

LOD

PEC

RABS

RTU

SCA

SEC

USP

biological safety cabinet

beyond-use date

compounding aseptic isolator

compounding aseptic containment isolator

Centers for Disease Control and Prevention

Controlled Environment Testing Association

containment primary engineering control

containment segregated compounding area

compounded sterile preparation

gloved fingertip and thumb sampling

hazardous drug

high-efficiency particulate air

heating/ventilating/air conditioning

International Standards Organization

laminar air flow system

laminar air flow workbench

line of demarcation

primary engineering control

restricted access barrier system

ready-to-use

segregated compounding area

secondary engineering control

United States Pharmacopeia


46


Patricia C. Kienle, Activity Chair 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, Pennsylvania. She completed an Executive Fellowship in Patient Safety from Virginia Commonwealth University and is Adjunct Associate Professor at Wilkes University in Wilkes-Barre, Pennsylvania.

Ms. Kienle has served on the ASHP Board of Directors and as President of the Pennsylvania Society of Health-System Pharmacists. She is a Fellow of ASHP and has been honored with the ASHP Distinguished Leadership Award and 2018 ASHP John W. Webb Lecture Award. Ms. Kienle has served on the Pharmacotherapy Specialty Council of the Board of Pharmacy 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 member of the USP Compounding Expert Committee and chairs the Subcommittee on Hazardous Drugs.

Ms. Kienle is co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, and author of The Chapter <800> Answer Book. With over 500 invited presentations and 50 publications, she has special interests in medication safety, compounding sterile preparations, accreditation, and regulatory issues.

Ashley M. Duty Pharm.D., M.S.

Clinical Pharmacy Operations Manager Children’s Mercy Kansas City, Missouri

Ashley Duty, Pharm.D., M.S., is Clinical Pharmacy Operations Manager at Children’s Mercy in Kansas City, Missouri. She earned a Doctor of Pharmacy degree from the Raabe Col-

lege of Pharmacy at Ohio Northern University and a Master of Science in Health-System Pharmacy Adminis-tration degree from Northeast Ohio Medical University. She completed an ASHP-accredited PGY1/PGY2 Health-System Pharmacy Administration residency at Cleveland Clinic in 2014.

At Children’s Mercy, Dr. Duty is responsible for 21 pharmacists in general medicine and hematology/oncology, as well as for USP Chap-ter <797> and USP Chapter <800> oversight for all sterile compounding operations. She also serves as the staffing preceptor for the accredited PGY1 and PGY2 residencies.

Dr. Duty’s professional interests include operations, medication safety, and informatics. She is also very passionate about leadership development. Within ASHP, she is a member of the Educational Steering Committee for the Section of Phar-macy Practice Managers. Previously she served as Chair and Vice Chair of the New Practitioners Forum. On the local level, Dr. Duty is Programs Chair for the Greater Kansas City Society of Health-System Pharmacists.

Dr. Duty completed the ASHP Advanced Sterile Product Prepara-tion Certificate in 2017 and served as a planner and presenter for both the PTCB-recognized ASHP Sterile Product Preparation Certificate and the Compounded Sterile Products Certificate for Pharmacists in 2019.

Eric S. Kastango B.S.Pharm., M.B.A., FASHP

President and CEO Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey

Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, is President and CEO of Clinical IQ LLC, a health-care consulting firm, and CriticalPoint, LLC, a web-based education company.

Mr. Kastango received a Bachelor of Sci-ence degree in pharmacy from Massa-chusetts College of Pharmacy and Allied Health Sciences and a Master of Business Administration degree from University of Phoenix. He completed 65 hours of training in nuclear pharmacy at Purdue University and 80 hours of didactic train-ing for the Six Sigma-Green Belt certifi-cation that he started with BD Medical Systems. At Johns Hopkins Bloomberg School of Public Health, he is working on a Certificate in Quality, Patient Safety, and Outcomes Research.

Mr. Kastango served on the USP Sterile Compounding Committee from 2005-2010 and 2010–2015 USP Council of Ex-perts, Compounding Expert Committee until April 2013. In May 2013, USP recog-nized Mr. Kastango and the members of Compounding Expert Committee with an Award for Outstanding Contribution to the USP Standards-Setting Process. He received an ISMP Cheers Award in 2015 for his work related to sterile compound-ing safety. Mr. Kastango also served on the USP Hazardous Drug Expert Panel from 2010–2016, and he is actively working with NABP and state boards of pharmacy to provide training to their sterile compounding inspectors.

Mr. Kastango is an active member and Fellow of ASHP, and he served on the Expert Panel for the ASHP Research and Education Foundation in the develop-ment of the 2015 Outsourcing Sterile Products Preparation Vendor Assessment Tool and ASHP’s Insourcing Readiness Assessment Tool.

ABOUT THE FACULTY

www.ashpadvantage.com/uspchanges

Additional Resources Coming Soonn Expert Insight—faculty commentaries

n Engaging the Experts—faculty discussions with William Zellmer

n Promotional Theater On Demand—proceedings of today’s session

About Promotional TheatersThis Promotional Theater, conducted at the ASHP 2019 Summer Meetings and Exhibition, is a promotional activity provided by Fresenius Kabi and is not certified for continuing education credit. The content of this Promotional Theater and opinions expressed by presenters are those of the sponsor or presenters and not of the American Society of Health-System Pharmacists.

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Strategies for Ensuring Compliance by the December 2019 ... · Update on USP Chapter : Strategies for Ensuring Compliance by the December 2019 Deadline • Member of the