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© C
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The Joint CommissionMedication Compounding
Certification Webinar for State
Boards of Pharmacy
March 15, 2017
Jennifer Hoppe, MPHSenior Associate DirectorState Relations
Robert Campbell, PharmDField SurveyorHospital Accreditation Program
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Medication Compounding Webinar - 2
Presentation Goals
�Participants will have an understanding of:
–Standards development process
–Overview of Joint Commission Certification Standards
–On-site Certification Process
–The pharmacy’s responsibilities post-review to submit Evidence of Standard Compliance
–How a state Boards of Pharmacy can rely on certification in their regulatory oversight
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Medication Compounding Certification Standards and Review Process Overview
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Standard Development Process
�Technical Advisory Panel (TAP)
developed
– 17 Members non TJC
– 12 support staff TJC
– Utilized to provide advice and comment
– Represented multiple organization sizes and settings
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Standard Development Process
Department Standards and Survey Methods
TAP
USPFDA
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Standards Development Process
Standard Application Standard Publication
Voice of Customer
Pilots
TAP
Learning Visits
USP/FDA
MDC Standards and Survey
Process
Standard Research
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Medication Compounding Standards
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Standards
�Medication Compounding Standards
– Adapted from USP 795, 797, 800*
– Five Chapters
–General Responsibilities
–Education, Training, and Evaluation
–Compounding Sterile Preparations
–Compounding Sterile and Nonsterile Preparations
–Compounding Nonsterile Preparations
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General Responsibilities
�Leadership responsibilities
�Staff responsibilities
�Patient or patient caregiver’s
education (Home Care only)
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Education, Training, and Evaluation
�Implementation and Training of Policies
and Procedures
�Initial and ongoing education and
training for compounding personnel
– Observation and demonstration of competency
�Knowledge and competency
concerning compounding equipment
and environment
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Compounding Sterile Preparations
�Work practices and environment based
on USP 797 risk level
– Low, Medium and High Risk
– Immediate use
– Single-dose and multiple-dose
– Radiopharmaceuticals
– Allergen extracts
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Compounding Sterile Preparations
�Verification of accuracy and sterility of
compounded sterile preparations
�Environmental quality control
�Verification of automated compounding
devices (ACDs)
�Maintaining the sterility, purity, and
stability of compounded sterile
preparations (CSPs)
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Compounding Sterile Preparations
�Transporting of compounded products
– Communicating Storage requirements when shipping items
– Education and training for patients/caregivers for proper storage, handling, and administration (Home Care Only)
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Compounding Sterile and Nonsterile Preparations
�Assigning beyond-use dates (BUD)
– Including extended BUD
�Hazardous medication compounding
�Requirements for Non-sterile
compounding
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Medication Compounding On-Site Review Process
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Review Process Overview
�Certification reviews performed by
trained pharmacist
�Number of review days based on
complexity and number of
compounding sites
�Reviews are “announced”
�Reviews are on a 2 year cycle
�Tracer methodology utilized during
review process
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MDC AgendaTime Activity
8:00 – 8:10 a.m.
(10 minutes)
Opening Conference
8:10 – 9:00 a.m.
(50 minutes)
Orientation to Program
9:00 – 10:00 a.m.
(60 minutes)
Reviewer Planning Session & Document Review
10:00 – 12:30 p.m.
(2 hours 30 minutes)Compounded Medication Tracers, Pharmacy Visits and Satellite Pharmacy Visits
12:30 – 1:00 p.m.
(30 minutes)
Reviewer Lunch
1:00 – 1:30 p.m.
(30 minutes)
System Tracer – Data Use
1:30 – 2:30 p.m.
(60 minutes)
Competence Assessment Session
2:30 – 4:00 p.m.
(1 hour, 30 minutes)
Issue Resolution and Reviewer Report Preparation
4:00 – 4:30 p.m.
(30 minutes)
Program Exit Conference
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Document Review
�Orientation to facility and confirm
identified compounding locations in
application
�Review Primary Engineering Control
Certification documentation
�Review Secondary Engineering Control
Certification documentation
�Review cleaning logs for daily and
monthly cleaning
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Pharmacy and Satellite Pharmacy Visits
�Validate environmental requirements
�Observe
– PEC cleaning/disinfection
– Staff preparation for medication compounding
– Compounding activity
– In process and final product Verification
Every effort will be made to observe every risk classification
compounded for hazardous and non-hazardous
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System Tracer – Data Use
�Discussion will include:
– Performance improvement approach and plan
– Performance improvement priorities identified for medication compounding processes
– Collection of data to monitor performance
– Activities to improve processes and outcomes
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Competency Assessment Session
�Staff competency file selection process
�Minimally
– Media fills
– Glove fingertip testing
– Most recent observation of compounding technique (including hazardous, if applicable)
– Didactic training (including hazardous, if applicable)
– Equipment training
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Post Review Follow-up
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Survey Analysis for Evaluating Risk(SAFER)
�A transformative approach for
identifying and communicating risk
levels associated with deficiencies cited
during surveys
�Helps organizations prioritize and focus
on corrective actions
�Provides one, comprehensive visual
representation of survey findings
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The SAFER Model
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Post On-site Review Process
�Pharmacy will be left with a preliminary
report at close of survey
�Reports are reviewed in central office
and finalized within 10 days
�All Requirements for Improvement
(findings) will require Evidence of
Standards Compliance (ESC) to be
submitted within 60 days
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SAFER Matrix
Placement
Required Follow-Up Activity
LOW / LIMITED
• 60 day Evidence of Standards Compliance (ESC)- ESC will include Who, What, When, and How sections
MODERATE / LIMITED,
LOW / PATTERN,
LOW / WIDESPREAD
• 60 day Evidence of Standards Compliance (ESC)- ESC will include Who, What, When, and How sections
MODERATE/PATTERN,
MODERATE/WIDESPREAD
• 60 day Evidence of Standards Compliance (ESC)- ESC will include Who, What, When, and How sections
• ESC will also include two additional areas surrounding Leadership Involvement and Preventive Analysis
• Finding will be highlighted for potential review by surveyors on subsequent onsite surveys up to and including the next full triennial survey
HIGH/LIMITED,
HIGH/PATTERN,
HIGH/WIDESPREAD
• 60 day Evidence of Standards Compliance (ESC)- ESC will include Who, What, When, and How sections
• ESC will also include two additional areas surrounding Leadership Involvement and Preventive Analysis
• Finding will be highlighted for potential review by surveyors on subsequent onsite surveys up to and including the next full triennial survey
Note: If an Immediate Threat to Life (ITL) is discovered during a survey, the organization immediately receives a preliminarydenial of accreditation (PDA) and, within 72 hours, must either entirely eliminate the ITL or implement emergency interventions to abate the risk to patients (with a maximum of 23 days to totally eliminate the ITL). Please see the Accreditation Process Chapter within the Comprehensive Accreditation Manual for more information.
Prioritized Follow-up Action
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Evidence of Standards Compliance (ESC) Process
�All findings will require the following
information on the corrective action:
– WHO, WHAT, WHEN and HOW
�Only for findings cited within the higher
risk areas (dark orange and red areas
of SAFER matrix), 2 additional
components:
1. Leadership Involvement
2. Preventive Analysis
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Types of Leadership Involvement
�Providing resources (e.g. staff, money,
expertise)
�Serving as a champion of the change
�Direct participation on teams
�Motivating employees
�Establishing intervals for
communication and/or reporting
�Direct oversight of change*This list provides examples of leadership involvement. It is not an
exhaustive or prescriptive list as to how organizations should incorporate leadership involvement into the corrective action plan.
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Preventive Analysis
�Ensures the corrective action does not
simply fix the issue at hand
�Focuses on identifying and addressing
underlying reasons that caused the
issue
�Efforts also focused on preventing
future occurrences of the high risk
issue
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Certification Decisions
�Once a pharmacy’s ESCs are reviewed
and accepted, the organization will be
awarded Medication Compounding
certification
�If unacceptable ESC, pharmacy does
have 2nd opportunity to re-submit
�If 2nd ESC is unacceptable, the
pharmacy will NOT be awarded
certification
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Intracycle Activities
�On-site Evidence of Standards
compliance validation review
�Unannounced for-cause review:
– Concern over patient safety issues/serious standards compliance
– Indication that the organization is not in compliance with our Information Accuracy and Truthfulness Policy
�Outreach to facility if lower/medium
priority concerns are received.
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Opportunities for State Boards of Pharmacy to Rely on
The Joint Commission’s Medication Compounding
Certification Program
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State Recognition and Reliance:
�The acceptance of, requirement for, or
other references to the use of Joint
Commission accreditation or
certification, in whole or in part, by one
or more governmental agencies in
exercising regulatory authority.
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Developing State “Recognition”
�States adopt statutes and regulations that enable state agencies to use certification as a basis for making licensure decisions –forgoing the need to conduct a routine on-site inspection
�Similar to federal deemed status (hospital, critical access hospital, hospice, home health, lab, ambulatory surgical center)
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Value of Recognition From Regulatory Perspective
�Provides an independent third party evaluation
�Provides assurance that pharmacies are compliant with state regulations/USP requirements
�Flexibility to update standards in timely manner
�Provides the ability to direct resources toward other oversight activities
�Eliminates redundancy
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State Relations Communications
�Serve as liaison to state regulatory agencies
– Provide certification status updates
– List of certified pharmacies in state
– Complimentary copies of standards
– Shared experiences/best practices from other
state agencies
�Opportunities for Information Sharing
– State boards of pharmacy can enter into
information sharing agreements with the Joint
Commission to facilitate:
– Advance notice of review schedule
– Sharing of high priority complaints
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Contact Information:
Jennifer Hoppe
Senior Associate Director
State Relations
The Joint Commission
Phone: 630-792-5261
E-mail: [email protected]