What to Expect When AABB Comes to Visit

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What to Expect When AABB Comes to Visit

• Kim Charity,
• BS, MT(ASCP),
• CQA(ASQ)
• Accreditation and Quality
• AABB

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Purpose of Assessment

• To determine compliance with established
  Standards
• Peer review
• Education

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The Expectation

• You are always prepared for an assessment

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Why Unannounced?

• To increase public trust in assessment process
• Recent GAO report expressed concerns about
  integrity of inspections where facility receives
  prior notification of date
• CMS has placed restrictions on accrediting
  organizations regarding scheduling of
  assessments/inspections

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AABB Standards

• Published every 18 months to 2 years
• 4-month implementation period
• Assessment tools posted on the AABB Web Site
  within that period
• Begin assessing on effective date of applicable
  Standards

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AABB Quality System Model
Work Operations Processes
Collect Process Test Distribute
Transfuse
Quality System Essentials Organization Resources E
quipment Supplier and Customer Process
Control Document/Records Deviations,
Nonconformances Assessments Process
Improvement Facilities and Safety
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Quality System Documentation Hierarchy
POLICY DOCUMENTS (what will be done)
Quality Manual Level A
PROCESS DESCRIPTION DOCUMENTS (how it happens)
Quality System Process Descriptions Level B
PROCEDURE DOCUMENTS (how to do it)
Standard Operating Procedures (SOPs) Level
C Forms, Labels, Reports
RECORDS (what was done)
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• How Do I Get Ready?

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Tools To Prepare For Assessments

• Standards for activities to be assessed
• AIM Accreditation Information Manual
• Blood Bank Regulations A to Z
• www.aabb.org

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www.aabb.org

• AIM
• Standard Source
• Association Bulletins
• Commendable Practices Library
• Facility Guide Through the Assessment Process
• Assessment tools for activities to be assessed

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Assessment Tool
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Self-Assessment Process

• Utilizes Standards and assessment tool
• New services seeking accreditation
• Gap analysis
• Identify areas of nonconformance
• Develop a corrective action plan
• On-going process for all services
• Use one section at a time
• Focus on critical control points

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Getting Ready Helpful Hints

• Have a plan!
• Activities
• Timeline
• Involve your staff
• To develop policies, processes, and procedures
• To find areas of nonconformance

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Getting Ready Helpful Hints

• Involve executive management
• Practice with staff
• Use outside sources
• Other professionals
• Other hospitals

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Getting Ready Facility Process
How to Manage an External Audit

• Who is responsible?
• Who is needed?
• Direction for staff at the front desk
• Direction for staff who might interact with
  auditor(s)

• Assigned escorts
• Needed documents and records
• Arrangements for lunch
• Clean work area

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Accreditation Process

• Defined in AIM
• Lists
• Action steps (What is to happen)
• Responsible person (Who is to do it)
• Documents (Using what forms)
• Covers a timeframe of 7 months

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Accreditation Process

• 7 months before expiration date
• Fax to facility
• Confirm
• Accreditation information contact
• Credentials
• Title
• E-mail address
• Medical director

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Renewal Packet Color- Coded Forms

• Yellow Complete and return within 10 days
• Facility Data Verification Record
• Data Form for Additional Activities
• Locations Table
• CLIA form
• Pink Complete and return with preassessment
  materials
• Planning form
• Facility Information Update
• Annual Statistic Table
• Green Information only
• Assessment Process Checklist
• On-site documents and records
• FAQs Unannounced Assessments

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Return Within 10 Days ?

• Facility Data Verification Record (FDVR)
• Demographic information
• Activities for accreditation
• Request for AABB-CAP coordination
• Data Form for Additional Activities
• CLIA form
• Locations Table

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Revised Locations Table

• Used by facilities with multiple sites
• New information required
• Site Contact Person
• Distance from the main facility
• Will facility provide transportation?

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Accreditation Process

• FDVR received at National Office
• Information entered into database within 2 days
• Assessment team assigned within 14 days

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Accreditation Process

• Assessors respond within 24 hours of assignment
• Reassignments if assessors decline
• Facility is notified of composition of assessment
  team
• Facility accepts/declines team within 7 days
• Reassignments if assessors are declined

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Accreditation Process

• Facility submits preassessment materials within
  24 hours of accepting assessment team

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Pre-assessment Materials

• Used by the assessor to
• Understand the scope of the assessment
• Understand the structure of the facility
• Understand the basic quality processes of the
  facility
• Identify areas to focus on during the onsite visit

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Preassessment Materials

• Annual Statistics Table ?
• Planning Form ?
• Facility Information Update ?
• Original FDVR
• Organizational Chart
• Overview of Quality Plan
• Master List of Documents
• List of Internal/External Assessments
• List of Proficiency Tests
• Relationship Testing 4 cases

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Planning Form

• Blackout dates
• You may choose 5 days in the quarter
• Select 5 days - not date ranges
• Hours of operation
• Time that staff will be available to participate
  in the assessment
• Parking
• Security requirements
• Airports in the area
• Hotels in the area

• Note if your facility is on a large campus, put
  yourself in the visitors shoes anticipate the
  logistical information they will need to find
  their way around the facility.

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The Process Continues...

• Packet prepared and sent to assessment team
• Lead assessor coordinates agreeable assessment
  date with team
• Team performs desk assessment
• Lead prepares an assessment schedule and sends to
  team

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AABB/CAP Coordination

• The AABB assessment must occur in the AABB cycle
  and prior to the CAP anniversary date
• AABB assessor must complete CAP team member
  training
• Assessor completes AABB assessment and CAP
  checklist

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AABB/CAP Coordinated Assessments

• Coordinated does not necessarily mean AABB and
  CAP team will arrive on the same day

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AABB/CAP Coordinated Assessments - Example

• AABB fourth quarter (Oct Dec 2009)
• CAP Anniversary Date Dec 10, 2009

• CAP Team
• Sept 10Dec 10
• AABB Team
• Oct 1-Dec 10

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AABB/CAP Coordinated Assessments - Example

• AABB fourth quarter (Oct Dec 2009)
• CAP Anniversary Date Jan 10, 2010

• CAP Team
• Oct 10Jan 10
• AABB Team
• Oct 1-Dec 31

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AABB/CAP Coordinated Assessments

• Assessors will have a minimum of 1 month for
  assessment
• CAP anniversary date Oct 31
• Assessment occurs Oct 1 Oct 31
• CAP anniversary date Oct 20
• Cycle changes to third quarter (July-September)

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Blackout Dates

• AABB will only honor 5 blackout dates
• Dates must be listed on AABB Planning Information
  form
• Assessors WILL NOT use blackout dates in CAP
  packet

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New for 2008

• CAP TRM AABB BB/TS Standards Crosswalk
• AABB Web site
• Members Area gt Accreditation gt Assessors

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The Day Arrives!
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Who Are These Assessors?

• Staff assessors
• Lead assessments for blood centers, HPC labs,
  cord blood banks, perioperative services, and
  relationship testing labs
• Conduct and manage audits
• Expertise in quality systems
• Volunteer assessors
• Knowledge of and experience in activity to be
  assessed
• Trained as assessors

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Assessor Resources
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Assessor Resources

• Standards
• Assessor Handbook
• Assessment Tools

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New for 2009

• Advance notification of assessment
• E-mail to accreditation contact, medical director
• Assessment will occur within one week of this
  notification

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Assessment Overview

• Opening meeting
• Tour
• Review of SOPs and records
• Observation of procedures
• Staff interviews
• Summary session

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System-based Assessment

• Service has an operational quality management
  system
• Policies, processes, and procedures have been
  developed and implemented
• Quality management system allows for consistent
  execution of policies, processes and procedures

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System-based Assessment

• Review documents
• Interview staff
• Observe staff
• Sample records
• Verify implementation of processes and procedures
• Corroborate information
• Review objective evidence

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What Are Assessors Looking For?

• A process to review new standards and
  requirements
• A process to compare new requirements to current
  SOPs
• A process to update SOPs
• A process to approve SOPs
• A process to validate SOPs
• A process to train staff

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Then

• Implementation of processes
• Evidence of review
• Evidence of change control
• Evidence of approval and validation of SOPs
• Evidence of training and competence records

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Assessment Using Tracers

• Pick a product
• Review all elements of QSEs related to that
  product

Training/Competency Equipment Validation Supplies
Procedures
QC Administration Records Reviews
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Assessment of a New Process

• Does your quality system work?
• Is there change control for the new process?
• Are SOPs written for the new process?
• Are the SOPs approved?
• Has the process been validated?

• Is the staff trained?
• Is the staff competent?
• Are the SOPs implemented?
• Are procedures performed per SOP?
• Does the product meet specifications?

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Anything Else?

• Were nonconformances identified during the
  previous assessment?
• Has the facility followed through on the
  corrective action plan that was submitted?

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Assessor Clues for Non-Compliance

• Quality Programs are all in training
• Standard Operating Procedures (SOPs) were
  implemented or revised recently
• SOP annual review was just completed

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More obvious clues

• Medical Director review
• Quality Control and Maintenance review
• Assessment dates
• Quality Assurance staff has recently pulled their
  hair out!

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Whats Next from the Assessor

• Ask more questions
• Review more records
• Lengthen their visit
• Dig, Dig, Dig

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Standards Interpretation Form

• A process for obtaining clarification of a
  Standard by the Standards Committee

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Summary Session

• No surprises!
• What standards were not met?
• Objective evidence
• Opportunity to ask questions, discuss findings

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Failure to Meet Requirements

• Nonconformance
• A policy/process/procedure not defined or
  documented
• Multiple implementation failures
• Requires the facility to submit a written plan of
  corrective action within 30 days of the assessment

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Corrective Action Plan

• Remedial (immediate) action
• Root cause analysis
• Corrective (long term) action and
• system improvements
• Process control checks (monitoring for
  effectiveness)

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What is Root Cause Analysis?

• Root Cause Analysis is a structured investigation
  that aims to identify the true cause of a
  problem, and the actions necessary to eliminate
  it.

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Look for Common Threads

• Is it a document development issue?
• Is there a problem with the review process?
• Is it a document control issue?
• Is there a problem with the training process?

WHY??
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RCA SOP Development

• Why is the process used to develop SOPs failing
  to assure that procedures address all
  requirements?
• Why, when new standards are introduced, does the
  process to develop SOPs fail to create
  new/revised procedures?
• Why does the process used to review SOPs not
  detect failure to conform to standards?

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RCA Training

• Why is the process used to develop training
  failing to ensure that implementation of SOPs
  occurs and that staff is competent?
• Why is the process used to train personnel
  failing to ensure that personnel are aware of
  procedures and how to perform required duties?
• Why are personnel not following procedures?

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RCA Document Review

• Why is the process used to review SOPs and forms
  failing to ensure that the contents are
  up-to-date?
• Why does the process to archive documents fail to
  ensure obsolete documents are not in use?

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What to Correct?

• Goal of Corrective Action to prevent the
  reoccurrence of the same or similar situation
• Is there enough information?
• Is the information accurate?
• What steps should be taken to correct the
  problems identified in root cause analysis?
• Is the planned corrective action relevant to the
  problem?

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CA/System Improvements

• Description of the action taken to prevent
  recurrence of same or similar nonconformance
• Timeline for the completion of the action
• Individuals responsible for overseeing the
  completion of the action

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Plan for Monitoring CA

• Monitoring the effectiveness of CA is critical
  for ensuring that the causative factors of the
  incident have been identified and corrected

• Indicator tracking
• Error tracking
• Direct observation
• Paperwork review
• Focused audits
• Combination of these

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Back at AABB

• Corrective action plan is reviewed by two
  technical specialists
• Additional information may be requested
• Evidence of implementation may be requested
• Certificate is issued upon final acceptance of
  the plan

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Im Done Now, Right?!!
NO!
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Staying Ready for Assessments

• Implementation and monitoring of CAPlan
• Introduction of New Standards
• Comment period
• Make your thoughts known!
• 4 month implementation period
• Develop a plan
• Implement
• Internal assessments
• Process improvement

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Conclusion

• Quality is never an accident it is always the
  result of high intention, sincere effort,
  intelligent direction and skilled execution it
  represents the wise choice of many
  alternatives unsigned plaque