Medication Compounding Certification Webinar for State ...€¦ · Patient or patient caregiver’s...

1

© C

opyri

ght,

The J

oin

t C

om

mis

sion

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

© C

opyri

ght,

The J

oin

t C

om

mis

sion

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

2

© C

opyri

ght,

The J

oin

t C

om

mis

sion

Medication Compounding Certification Standards and Review Process Overview

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

3

© C

opyri

ght,

The J

oin

t C

om

mis

sion


Standard Development Process

Department Standards and Survey Methods

TAP

USPFDA

© C

opyri

ght,

The J

oin

t C

om

mis

sion


Standards Development Process

Standard Application Standard Publication

Voice of Customer

Pilots

TAP

Learning Visits

USP/FDA

MDC Standards and Survey

Process

Standard Research

4

© C

opyri

ght,

The J

oin

t C

om

mis

sion

Medication Compounding Standards

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

5

© C

opyri

ght,

The J

oin

t C

om

mis

sion


General Responsibilities

�Leadership responsibilities

�Staff responsibilities

�Patient or patient caregiver’s

education (Home Care only)

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

6

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion



�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)

7

© C

opyri

ght,

The J

oin

t C

om

mis

sion



�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)

© C

opyri

ght,

The J

oin

t C

om

mis

sion


Compounding Sterile and Nonsterile Preparations

�Assigning beyond-use dates (BUD)

– Including extended BUD

�Hazardous medication compounding

�Requirements for Non-sterile

compounding

8

© C

opyri

ght,

The J

oin

t C

om

mis

sion

Medication Compounding On-Site Review Process

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

9

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

10

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

11

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion

Post Review Follow-up

12

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion

The SAFER Model

13

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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


MODERATE/PATTERN,

MODERATE/WIDESPREAD


• 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


• 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

14

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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.

15

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

16

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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.

© C

opyri

ght,

The J

oin

t C

om

mis

sion

Opportunities for State Boards of Pharmacy to Rely on

The Joint Commission’s Medication Compounding

Certification Program

17

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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.

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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)

18

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

© C

opyri

ght,

The J

oin

t C

om

mis

sion


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

19

© C

opyri

ght,

The J

oin

t C

om

mis

sion


Contact Information:

Jennifer Hoppe

Senior Associate Director

State Relations

The Joint Commission

Phone: 630-792-5261

E-mail: [email protected]

Medication Compounding Certification Webinar for State ...€¦ · Patient or patient caregiver’s...

Documents

Transcript of Medication Compounding Certification Webinar for State ...€¦ · Patient or patient caregiver’s...