Service Innovations Webinar Series

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Service Innovations Webinar Series Errors in Surgical Pathology - Lessons from the Blood Bank

Elzbieta B. Griffiths, MD, FCAP Deborah B. Gordon, MD, FCAP

July 25, 2012

Welcome!

• Service Innovations Webinar Series: Drive wider adoption of value added services by sharing how they’ve been implemented by others.

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• Disclaimer: Opinions expressed by the speaker are the speaker's own and do not necessarily reflect an endorsement by CAP of any organization, equipment, reagents, materials or services used by participating laboratories.

2012 College of American Pathologists. All rights reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes in any way. 2

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2012 College of American Pathologists. All rights reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes in any way.

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About the Presenters

Elzbieta B. Griffiths, MD, FCAP • Medical Director of the Blood Bank and Blood Donor

Center and a Surgical Pathologist at Mount Auburn Hospital in Cambridge, MA

• Assistant Clinical Professor, Tufts University School of Medicine • Chair of the hospital’s Transfusion Review Committee • Member of the Medical Advisory Committee,

American Red Cross Northeast Region • Board certified in AP, CP, and Transfusion Medicine

Deborah B. Gordon, MD, FCAP • Medical Director and Chief of Pathology at

Heywood Hospital in Gardner, MA • Chair of the hospital’s Transfusion Review Committee • Member of the Medical Advisory Committee,

American Red Cross Northeast Region • Board certified in AP and CP

4 2012 College of American Pathologists. All rights reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes in any way.

Objectives

• Describe how a blood bank-modeled quality system can benefit Anatomic Pathology (AP).

• Explain how data collection, analysis and trending are used in a Quality Management and Improvement (QMI) system.

• Illustrate how QMI increases efficiency, decreases errors and costs, and improves patient care.

• Describe how implementing this approach increases the value of the pathologist to the health care system and patient care team.

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Quality Management (QM)

• Importance: o essential part of the health care system and an evolving

science.

• Patient care: o good services, reliable high quality results delivered in an

efficient, timely manner to allow best diagnosis and treatment.

• Systems: o ensure and improve safety and quality of services

provided and require continuous attention and adjustments.

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Quality Management Benefits

• Satisfied patients and caregivers

• Appropriate use of resources

• Containment of costs

• Supports the goals of “The Patient Safety and Quality Act of 2005” and the quality based reimbursement models

• Pathologist as a leader in the changing health care system

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Why Lessons From Blood Bank?

• Blood bankers: leaders in a systematic development/ implementation of comprehensive QM programs

• Major driving force: o Clinical implications of Blood Bank errors o Regulatory requirements o Restoring and maintaining public trust

• Systematic approach to QMI an expectation in Anatomic Pathology and Laboratories

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Mt. Auburn Hospital (MAH) Blood Bank QMI Principles:

• Team work, non-punitive culture, communication

• Quality is everyone's responsibility

• Staff has input into development of procedures

• Errors can occur at any step in the process

• Most errors are system related

• Errors as a learning experience

• QMI is an ongoing process requiring continuous attention and process adjustments

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MAH Blood Bank QMI Program

• Errors/problems included in analysis: o Transfusion related incidents filed in the hospital wide

incident reporting system (“Risk Monitor Pro”®)* o Transfusion Errors/Problems not included in hospital

system

• CDC’s Hemovigilance Incident Codes for error classification www.cdc.gov/nhsn

• All errors/problems are classified, logged on Internal Incident Report form, assigned chronologic numbers and entered into Blood Bank database

* One of several electronic reporting systems currently available.

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http://www.cdc.gov/nhsn�

MAH Blood Bank QMI Program (continued)

• Hospital wide error reporting system o Major triggers for entering:

− Blood administration errors (no consent, wrong product given, mistransfusion)

− Specimen collection errors (mislabeling, wrong tube) − Patient identification errors − Delays in transfusion (lack of orders, wrong order,

miscommunication)

• All other problems are logged on the Internal Incident Report form.

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Share your ideas and experiences

• Do you use a hospital-wide computerized error reporting system at your institution?

o Yes o No

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0

50

100

150

200

250

2008 2009 2010 2011

Mt Auburn Hospital Blood Bank Specimen Labeling Error Reduction (since rL system introduced)

Mis-Labeled Specimens

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(Missing middle initial, phlebotomist initial, etc.)


Blood Bank Specimen Labeling Error Reduction

• How did we do it? o Collaborative team approach with

Nursing Administration, Quality and Safety Dept. and the Blood Bank

o Root cause analysis- failure to follow procedures, clerical errors, tube label too small

o Corrective action plan- comprehensive educational efforts; change in the size of the tube label

o Ongoing monitoring

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Proposed QMI Approach for AP

• Errors can occur anywhere in the process from collection to the final report transmission

• Most errors are due to a process/system problem not due to an individual*

• Systematic, process oriented approach to QM similar to that used by blood bankers would be useful for AP

* Raab S. AP Errors and Patient Safety Editorial. Pathology Case Reviews. 2005;10(2):61-62

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Quality Management in AP

The AP process is divided into three phases:

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Pre-Analytic Analytic Post-Analytic

Specimen Generation

Microscopic Examination/

Diagnosis

Specimen Accession

Transcription

Transmittal / Charting

Gross Processing/ Examination

Report Generation

Surgical Procedure

Clinical Presentation

Specimen Transport

Report Interpretation


ANATOMIC PATHOLOGY

Source: Jan Silverman MD. The Anatomic Pathologists Role in Error Reduction and Patient Safety. ASCP 2011 Annual Meeting.

Histology/Slide Preparation

Three Phases of the AP Processes

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Pre-Analytic Errors

• Collection (contamination, wrong fixative, inadequate specimen)

• Labeling (identifiers, sources)

• Transport (delays, loss)

• Accessioning

• Processing (histology, slide prep)

Pre-Analytic

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Analytic Errors

• Gross Examination/Processing

• Frozen section

• Microscopic diagnosis

• Surgical Pathology report

• Additional/confirmatory testing not ordered (eg, Molecular Diagnostics, Immunohistochemistry)

Source: Nakhleh R, Zarbo R. Surgical Pathology Specimen Identification and Accessioning. APLM. 1996;120

Analytic

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Post-Analytic Errors

• Transcription errors

• Critical value notification

• Turn around time

• Report delivery to wrong provider

• Failure to perform QA (eg, random and/or focused review)

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Post-Analytic

Quality Management in AP

• Historically most of the focus has been on diagnostic errors i.e. analytic and the individual pathologist.

• However: o Analytic errors are rare o Approximately 80% of AP errors are Pre-Analytic

Source: Nakhleh R, Zarbo R. Surgical Pathology Specimen Identification and Accessioning. APLM. 1996;120

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Clerical Error in Pathology Report Leads to Unnecessary Hysterectomy

http://www.boston.com/news/local/massachusetts/articles/2012/05/27/mass_hospitals_urged_to_apologize_settle/

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http://www.boston.com/news/local/massachusetts/articles/2012/05/27/mass_hospitals_urged_to_apologize_settle/�

http://www.boston.com/news/local/massachusetts/articles/2012/05/27/mass_hospitals_urged_to_apologize_settle/�

Source: Condel et al. Histology Errors, Use of Real –Time Root Cause Analysis to Improve Practice. Path Case Rev. 2005;10:2

The Toyota Production System (TPS) shows that most errors are systemic and NOT a problem caused by an individual.

Error identification and system adjustments lead to more efficiency, less wastage, higher quality and more satisfaction.

Roadblocks to Change in QM Approach in AP

• Lack of awareness • “Blame” and “Work around” culture

An Industry Example

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• Do you have a QMI program for AP which evaluates the entire process, pre-analytic, analytic and post-analytic?

o Yes o No

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Proposed QMI Approach for AP - Key Elements

• Surgical Pathology Incident Code list : o Identification of steps in AP process o Identification of all possible errors within each step

• Each step was assigned a specific code o Specimen Processing – code SP 00

• Errors in each step were assigned a specific error code o SP05 quality of sections o SP06 quality of stain

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Proposed QMI Approach for AP - Key Elements

• AP process phases: o Pre-analytic – code P1 o Analytic – code P2 o Post-analytic – code P3

• Key Quality Triggers: o KY 01 Delay in Final Report o KY 02 Process Problem o KY 03 Wrong Diagnosis o KY 04 Services Not Performed o KY 05 Clerical Error

© 2012 College of American Pathologists. All rights reserved. 28

Benefits of the Codes

• Allow error analysis/trending at several levels of detail: o AP process phase (using P1, P2, P3)

o Step in the process (e.g. PO physician orders/pathology requisition)

o Individual errors ( e.g. PO 03 Clinical data not provided)

o Key Quality Triggers/Outcomes (e.g. KY 02 process problem, KY03 delay in final report)

• Provide standardization of error reporting

© 2012 College of American Pathologists. All rights reserved. 29

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Case Study I

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Error Evaluation and Root Cause Analysis

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Root Cause Analysis (RCA)

• Description: A structured approach to identifying the factors that

resulted in the type, seriousness, location, and timing of the harmful consequences of a past event

• Purpose: To identify behaviors, actions, conditions which need to be changed to prevent future recurrence; identify lessons to be learned.

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• Have you participated in a Root Cause Analysis for an error in AP?

o Yes o No

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Case Study II

• 63-year-old female with a suspicious mass on mammogram; core biopsy “Benign breast tissue”

• Correlation of radiologic-pathologic reports led to recommendation for excision

• Slides reviewed by the original pathologist prior to excision

• Revised diagnosis “Infiltrating ductal carcinoma”

• Serious error requiring RCA

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Case Study II (continued)

• Error was identified and documented

• Immediate analysis/action taken: Chiefs of the Departments notified, amended report issued and patient notified by surgeon.

• RCA was performed using “the 5 whys”: o near miss; no adverse clinical consequences o 2 breast biopsies in the same folder led to error

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Case Study II (continued)

• Corrective action plan: o Placing each breast biopsy case in a

separate folder o Changing ink color of sequential core biopsies o Review by a second pathologist of all

breast biopsies

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Data Analysis and Trending

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Data Analysis and Trending

• Every incident is evaluated in 2 ways: o Individually

−Documentation, classification, immediate evaluation and corrective action

o As a group to determine any possible trends −Periodic analysis of all incidents to search for

recurrent errors/problems −Recurrent problem as a new quality indicator −Development of a quality improvement plan

to address the new indicator

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Data Analysis and Trending (continued)

• Should not be complex.

• Choose methods based on size, type and needs of the organization.

• Paper, spreadsheet or software can be used for data analysis and trending.

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Paper Data Collection, Analysis & Trending

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Spreadsheet Data collection, Analysis & Trending

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0

2

4

6

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Series1

Errors by Type Using Codes

0 2 4 6 8

10 12

SP06 Quality of Stain

Number

Moving Average

Software

• Create Database (DB) using DB software (MS Access®*)

• Purchase pre-configured software

• Most powerful method for data analysis and trending

• Most complex to develop

* One of many software programs available.

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AP Errors by Process Phase

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Phases

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SC01 SC07 SP01 SP04 SP05 SP06 SP08 SP14 SP15 EE05

SC01 Specimen Mislabeled SC07 Fixative Problem SP01 Specimen ID Error SP04 Tissue Processing/Fixation SP05 Quality of Sections SP06 Quality of Stain SP08 Delay in Processing SP14 Transcription Delay SP15 Transcription Error EE05 Tissue Processor

Pre-Analytic Phase (P1) Error Detail

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Error Trending

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2

4

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Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec

SP06 Quality of Stain

Number

Moving Average

Quality Improvement Plan

• Develop plan to address the new indicator selected o Investigate all possible contributing factors

o Define the corrective action steps and time table needed to address these factors

o Assign individuals responsible to carry out the plan

o Cost / Benefit analysis

• Plan implementation

• Post implementation analysis and tracking

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Summary

• Systematic process-oriented QMI in AP: o Detects non-diagnostic and diagnostic errors o Provides standardization of error reporting

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o Allows error analysis at several levels of error detail

o Leads to continuous process improvement through analysis, trending and new quality indicators

o Decreases errors, costs and improves efficiency, patient care and staff satisfaction

o Teamwork and collaboration are essential

Summary (continued)

• Systematic process-oriented QMI : o Does not need to be complex and can be adjusted to the

needs of the institution

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o Pathologists become leaders in the changing healthcare system

o Expected in evolving Accountable Care Organization –centered model

• Uniform classification of errors in AP would enable inter-laboratory comparisons and information exchange.

Next Steps

• Join us in a CAP-sponsored LinkedIn discussion group.

• Develop a pilot program to implement QM in AP which detects and analyzes errors at each critical step using the approach presented.

• Share your experiences if you have an existing QMI program for AP that detects and analyzes errors in all phases of the AP process leading to process improvement.

• Become a leader by decreasing errors and costs and ultimately improving patient safety and outcomes.

•

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Acknowledgements

• Carmine Vetrano, MM (HC); Blood Bank Manager, Mt. Auburn Hospital

• David R. Griffiths, BS, MBA, MCSE; Philips Healthcare

• BJ Magnani, MD, PhD; Chair and Pathologist-in-Chief Department of Pathology, Tufts Medical Center

• Brinda R. Kamat, MD, MPH; Chair, Department of Pathology, Mt. Auburn Hospital

• Debra Steward, BS; Laboratory Administrator, Mt. Auburn Hospital

• Dawn Burns, MT; Blood Bank Supervisor, Heywood Hospital

• Daniel Rosenberg, MD, FACEP

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Questions and Comments?

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Thank you for participating, today!

Reminders:

• Please join the online collaboration group and invite others to join! You will receive an email tomorrow.

• Your feedback is valuable. Please complete the evaluation to be emailed to you shortly.

• Next Service Innovations Series webinars:

August 30 11-12 CDT

The Integrated Pathologist: A Breast Cancer Reporting Example

presented by Dr. David Hicks

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