Pharmacy Quality Pharmacy Quality CommitmentCommitment

A Way to Improve Patient Safety

Confidential Training

AgendaOverview of 2005 Patient Safety Act

Discussion of Patient Safety Organizations

Pharmacy Quality Commitment

Quality SupervisorQuality Related Event (QRE)

Quality Assurance (QA)Continuous Quality Improvement (CQI)

Patient Safety Work Product (PSWP)

“We must accept human error as inevitable – and design around that fact.”

-Dr. Donald M. BerwickFormer Administrator, Centers for Medicare and Medicaid Services (CMS)

Institute of Medicine Reports – there is a problem!

• To Err is Human: Building a Safer Health System (1999)o 7,000 deaths from medication errors

• Crossing the Quality Chasm: A New Health System for the 21st Century (2001)o Patient Safety: Achieving a New Standard for Care (2003)

Need for an information infrastructure

o Preventing Medication Errors: Quality Chasm Series (2006)

At least 1.5 million ADEs occur each year

The Focus on Quality

• Provided for the creation of Patient Safety Organizations (PSOs) and establishes Network Patient Safety Databases (NPSD).

• Patient Safety Act GOALS:1. Encourage

1. Promote

3. Share

Patient Safety and Quality Improvement Act of 2005

PSOs are federally listed non-governmental organizations that collect QA data from members

Operate independently, without a relationship to regulatory and/or accrediting bodies

Benefits only extend to member pharmacies

Duties to maintain confidentiality and security

Duties to analyze data and provide feedback

Patient Safety Organizations: protect your

QA data

Includes protections from:

Discovery or Subpoena or FOI request or Evidence Federal, State, or local civil, criminal, or administrative

subpoena or order, including disciplinary proceeding

Limited disclosures allowed for certain criminal proceedings.

If you are uncertain, an attorney should be consulted to help protect your privileges and rights.

PSO Protections

PSO privileges do not protect:

• Patient's medical record• Billing and discharge information• Any other original patient or provider record• Prescription vials, labels, dispensing documents• Information collected, maintained, or

developed separately, or exists separately, from a patient safety evaluation system

What data is “discoverable”

Good business sense = protect patients AND business

State CQI laws (13 states)

CMS Requirement – 3rd Party Contracts

Accreditation and Credentialing programs have CQI requirements

Pharmacies need to have a program in place

The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) Entire dispensing process

Agency for Health Research and Quality (AHRQ) Incident = reaches patient Near miss Unsafe Condition

Institute for Safe Medication Practices (ISMP) Error, Near miss and close call (error happened/not

reached patient)

Alliance for Patient Medication Safety (APMS) Quality-related event (incident, near miss and unsafe

condition)

What is a Medication Error?

Near miss capture = successful ability to avoid disaster

What you do not measure, you cannot manage

“No news” is NOT

“good news”

= mistake/errormistake/error

Workflow Employees

Equipment

Technology

Swiss Cheese Effect

Development of a CQI System: Blueprint

PLAN: Take a systems view (Policies and Procedures/Culture/Education)

DO: Document all failures of quality (Collect the data)

CHECK: Analyze data to identify opportunities to improve for the future

(Review and meet with Staff)

ACT: Implement changes (Educate staff on changes and test results)

Repeat…

Pharmacy Quality Commitment®

~ PQC In store program pharmacies use in order to:

o Establish a quality conscious workflow o Identify, collect, and report Quality Related Events

(QREs)o Analyze QREs to identify process improvement

opportunities to improve workflow and decrease QREs

The APMS PSO provides :o Immediate access to the pharmacy’s reported patient

safety data in chart and graph formo Recommendations on best practices and workflow

processes to help reduce medication errors, improve medication use, and enhance patient safety and health outcomes

PQC helps you…..

Establish written CQI Policies and Procedures.  

Ensure that staff CQI training and/or education is provided to all pharmacy personel

Ensure that QREs are documented, reported, and analyzed

Maintain security of patient safety data

CQI Verified Certificate

A. Commitment to program (already have!)

B. Create culture of safety

C. Develop Policy & Procedures/Standardization

D. Institute process for collection, analysis and improvement cycle

How to Start?

B. Create a Culture

of Safety

Culture of Safety

Negative

Dwells on the past

Threatening, insulting, punitive

Focuses on WHO made an error

Concludes erring individual has character flaws they need to correct

Individuals won’t willingly participate

Positive

Looks to the future

Open, blame-free, non-punitive

Focuses on HOW or WHAT in the system allowed error to occur

Realizes error is a reality and recognizes the opportunities to improve for the future

Creates blame-free, shame-free environment

Discussing Errors

ISMP Medication Safety Self Assessment Tool www.ismp.org

AHRQ Pharmacy Survey on Patient Safety Culture htpp://www.ahrq.gov/qual/patientsafetyculture/pharmsurvindex.htm

Semi-quantitative measures of the “current state” in each pharmacy.

Self Assessment Resources

C. Develop Policies

and Procedures/

Standardization

 Policy:  Pharmacy will actively participate in Continuous Quality Improvement

Designate an individual or individuals responsible for monitoring CQI Program compliance

Identify and document QREs Minimize impact of QREs on patients Analyze data collected in response to QREs to assess causes and any

contributing factors Use the findings of the analysis to formulate an appropriate response and

develop pharmacy systems and workflow processes designed to prevent QREs Provide ongoing education

Procedures:Employee Training  Identification and Documentation of Quality Related Events

Root Cause Analysis (Investigative Analysis)

Process Improvements Records

QA Policies and Procedures(in Resource Area)

Basically….Review and sign. Educate Staff – Powerpoint in Resource Area

WHEN:  When and how patient safety data enters the PSES space

WHERE: Where it is protected – “where the dome covers”

WHO:  Who works with the data

WHAT: What data needs to be reported and what applies to it

 

HOW:  How you report and handle the data

(Mark it all CONFIDENTIAL Patient Safety Work Product)

Patient Safety Evaluation System(PSES)

(in Resource Area)

• Organized workflow• Use a systematic approach

• reduce the likelihood that a quality related event will be made• “Now where was I?”• Less likely to miss a step that could lead to an incident that

reaches the patient

• Quality does not happen by chance, it is a result of quality habits

• Redundancy is positive• Process ingrained

You Can Fix the System

13

No longer asking yourself this !

D. Institute process for

collection, analysis and

improvement cycle

Quality Related Events (QREs) Incidents that reach the patient whether they caused

harm or not Near Misses Unsafe Conditions

Both are important to track and analyze

Type, Who, What, Where, How, When and whether it reached the patient

Collect!

RECORD

:

#s and letters for easy recording

Fictional data for illustration purposes only

Completed Form

Example

Record QREs, THEN transfer to

the internet to pharmacy’s PQC

site

1.Go to www.pqc.net

2.Enter Username

3.Enter Password

Fictional data for illustration purposes only

1. Login

2. Enter report on correct day

3. Close your pharmacy each day (# of fills and refills)

Review – to Report

QRE’s

Communication?

Training provided?

Had procedures been reviewed?

Staffing?

Work area?

Policy & Procedure followed?

How to analyze – questions to consider

Intensive Investigation vs Root Cause Analysis

Peer Review – “Intensive Investigation”

1.What happened?

a. What happened on that

particular day?

2.Why did it happen?

a.What made that

particular day different?

b. What usually happens?

c. What should have happened

according to policy and

procedure?

1. Gather Quality Related Event (QRE). 2. Describe the QRE3. WHAT happened? WHY? HOW?

4. Identify possible failures in the systems.5. Identify possible contributing factors 6. Where in workflow the QRE occurred 7. Classify and record the causal factors and system failures. 8. Identify improvement plans. What would prevent this error in

the future? What will be monitored to assure that the corrective action is working?

Peer Review

 Process Improvement form

Date _______________Results of Peer Review ProcessProcess/Issue Identified Root Cause IdentifiedAction Planned  Date to be implemented Follow up analysis scheduled Results found at follow-up

Patient Safety Work Product

Privileged and Confidential

Inadmissible as evidence and not subject to Discovery 

* MARK all process improvement notes as PSWP and Secure this information in safe place in pharmacy or report directly to PSO

• Ideally will prevent the same event or minimize its occurrence

• PhysicalPhysical rather than proceduralInstall speed bumps instead of relying on speed limit sign

• PermanentPermanent rather than temporaryReplace equipment known to malfunction in the hands of “float” staff, instead of taping warnings or additional instructions on machine

Proposed actions should not burden people’s memory (i.e., “pay more attention next time”)

Actions and Changes

1. Positive Safety Culture2. Patient Safety Evaluation System3. Policies and Procedures4. Collect Data5. Analyze Data6. Implement New Process with Training

ReviewReview

Select Quality Supervisor

Review the training

Log in

Main Page > CQI Compliance Program Certification Enrollment

Complete Steps

Continue to report/Analyze

Implementation

www.medicationsafety.org APMS Web sitewww.pqc.net PQC Web site

Tara Modisett Executive Director APMS For assistance or questions email us at

info@medicationsafety.org or info@pqc.net Toll free (866) 365-7472

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