Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
To Err is Human
C. Brent Barrett, Ph.D., HCLD
Boston IVF
Harvard Medical School
DISCLOSURE
● Consultant and lab director for ReproSource Fertility 
Diagnostics
Outline and Learning Objectives
● To Err is Human:  A 10 year study of errors in an IVF lab
– Describe differences in lab ...
To Err Is Human:
Building a Safer Health System
“The title of this report encapsulates
its purpose. Human beings, in all
l...
“…deaths due to medical errors exceed the
number attributable to the 8th-leading cause
of death. More people die in
a give...
Errors in Health Care
● How big is the problem?
● In 1991, NEJM study which analyzed over 30,000 random 
selected records ...
0
1
2
3
4
Adverse events Negligence
Percent of admissions
Adverse events per hospitalization
Adverse event: injury caused ...
0
1
2
3
< 1 month 
impairment
1‐6 month 
impairment
Permanent 
impairment
Death  Deaths d/t 
negligence
Percent of hospita...
“As health care and the system that
delivers it become more
complex, the opportunities for errors
abound.”
Institute of Me...
Complexity in IVF lab
● Techniques
– Egg freezing and thawing
– Embryoscope/Eeva
– PGD/PGS and Day 5/6 biopsies
– PICSI, I...
Errors in ART
● “My lab doesn’t make mistakes”
● Tendency in medicine and our field to hide our mistakes
● Creates a sense...
“This report describes a serious
concern in health care that, if discussed
at all, is discussed only behind closed
doors.”...
Nonconformance database
● In March, 2003, Boston IVF became certified to the ISO 
9001:2000 quality standard 
● Standard r...
ART lab errors
● Reviewed our nonconformance database between March, 
2003 and November, 2013
– What errors are made?
– Ho...
Departments and procedures
● Phlebotomy/pre‐analytic procedures
● Endocrine
● Andrology
– SA; IUI and IVF sperm preparatio...
Study period
● March, 2003 ‐ November, 2013
● Total number of cycles = 31,715
– 25,764 egg retrievals
– 5,951 thaw cycles
...
Average number per year
● 2,417 retrievals
• 558 thaw cycles
• 2,364 IUI cycles
• 1,969 SA
• 14,660 procedures
Category
Communication Inter‐departmental 
communication problems
Documents/records Incorrect or incomplete 
documentation...
Category
Human An error such as performing 
a task outside of a 
documented protocol or a 
mistake or oversight which 
was...
Grading
● None/Minimal
– Error or problem occurred, but fully correctable or no 
measurable effect
● Moderate
– Serious er...
Grading
● Major
– A pregnancy or birth confirmed to have arisen from a 
misidentification of gametes or embryos 
– Systemi...
Example of Major
● Expert review at lab “X” (since closed)
– Reviewed all embryology and cryo records
– 9.5% of cycles wit...
Number
All Nonconformances
Andrology/Embryology
374
Statistical/QA 81
All Graded Errors 293
None/Minimal 219
Moderate 58
S...
0
10
20
30
40
50
60
70
80
90
100 None/ Minimal
0
5
10
15
20
25
30
35
40
45 Moderate
Significant
TYPE SEVERITY DESCRIPTION
Human  None/Minimal When preparing to do an embryo transfer I 
saw that the culture dish was pro...
TYPE SEVERITY DESCRIPTION
Human Moderate “John” (a new embryologist) was handling the dishes of pt P
during fertilization ...
TYPE SEVERITY DESCRIPTION
Equipment Significant I was using a 150um stripper tip to strip the eggs of pt R. I 
individuall...
Where are the errors made?
Number
None / 
Minimal 
(%)
Moderate (%) Significant (%)
Andrology 31 29 (93.5) 2 (6.5) 0 (0.0)
Cryo. / 
Storage
39 24 (61...
0.0%
0.1%
0.2%
0.3%
0.4%
0.5%
0.6%
0.7%
0.8%
Error rate per cycle
4.8
0.5 0.3
0.0006
0
1
2
3
4
5
6
CAP study on 
outpatient lab 
requisition errors
Clinical lab errors Transfusion errors B...
0.0%
0.1%
0.2%
0.3%
0.4%
0.5%
0.6%
0.7%
0.8%
How do our error rates compare?
Error rate per cycle
Bird et al., P-001, Asso...
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
HFEA A
Severe
HFEA B
Significant
HFEA C
Moderate
HFEA B&C
Moderate
and
Significant
B...
Comparison
Number 1 error per X 
cycles
Number of 
years for clinic 
with 400 
cycles/yr
Moderate 58 547 1.4
Moderate/Huma...
Number of embryologists/andrologists
Number of cycles ASRM (minimum #) High performing
labs*
250 3 2
500 4 4
1000 6 8
1500...
How are we doing?
“U.S. health care organizations
still have a ways to go to
achieve a culture in which all
errors are ope...
“…most importantly, we must systematically design
safety into processes of care. Errors can be prevented
by designing syst...
Disclosure to Patients
● 2011 ASRM Ethics Committee Report
● “Clinics have an ethical obligation to disclose errors out
of...
Disclosure
● Difficult
– Hard to admit mistake has been made
– Reputation
– Legal fears
– Blame focused on individual, not...
“Culture of truth-telling”
● Within lab
– Be upfront with embryologists about how errors are
handled and possible conseque...
Procedures for identification
● Witnesses for every step
– All SA and IUI specimens witnessed
– Wristband checks for all e...
How do we define Quality in ART?
● SART/CDC statistics
● Research
● Latest Technology
● PT and inspections
● Internally
– ...
Quality Management Systems
● What is a Quality Management System?
● What do you have in place at your clinic?
● Is it work...
ISO
● International Organization for Standardization
● Derived from Greek - isos - equal or standard
● NGO in 150 countrie...
ISO definition of Quality
“Degree to which a set of inherent characteristics fulfills
requirements.”
Requirements and Characteristics
● Requirements:
– Employees trained and competent
– Adherence to established procedures
–...
ISO 9001:2008 Summary
● One quality manager over entire system
● Documents and records are controlled,
organized and avail...
Summary
● 99.8% of cycles proceeded without error which affected cycle
● Errors are inevitable!
● We can ignore them or
● ...
Acknowledgements
● Drs. Denny Sakkas and Michael Alper for help with the
Error Study
● All those who have been involved in...
To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School
To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School
To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School
To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School
To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School
To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School
To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School
Upcoming SlideShare
Loading in …5
×

To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School

639 views

Published on

C Brent Barrett's talk, To Err is Human - a 10 year study of errors in an IVF lab, at the Southwest Embryology Summit, Las Vegas, January 2016

Published in: Science
  • Be the first to comment

To Err is Human, C Brent Barrett PhD, Boston IVF, Harvard Medical School

  1. 1. To Err is Human C. Brent Barrett, Ph.D., HCLD Boston IVF Harvard Medical School
  2. 2. DISCLOSURE ● Consultant and lab director for ReproSource Fertility  Diagnostics
  3. 3. Outline and Learning Objectives ● To Err is Human:  A 10 year study of errors in an IVF lab – Describe differences in lab errors in regard to type and  severity, to explain which errors occur more frequently in an IVF  lab and to compare error rates between organizations. ● Error Prevention through Quality Management – Understand the basics of a Quality Management System and  how it helps to prevent errors ● Going with the Flow – How to create and use Flowcharts – Understand why flowcharts are used, learn how to create a  flowchart and practice flowcharting
  4. 4. To Err Is Human: Building a Safer Health System “The title of this report encapsulates its purpose. Human beings, in all lines of work, make errors.” Institute of Medicine Report, 1999
  5. 5. “…deaths due to medical errors exceed the number attributable to the 8th-leading cause of death. More people die in a given year as a result of medical errors than from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516).” Institute of Medicine Report, 1999
  6. 6. Errors in Health Care ● How big is the problem? ● In 1991, NEJM study which analyzed over 30,000 random  selected records of hospitalizations in New York State in 1984  to determine the rate of adverse events which occurred and  the consequences of the events.   ● Although this study is over 20 years old and the data over 30,  it is still the definitive study in this area due to the size of the  study.  Many other smaller studies, both in the US as well as  other countries, have also been performed since and the  findings are similar
  7. 7. 0 1 2 3 4 Adverse events Negligence Percent of admissions Adverse events per hospitalization Adverse event: injury caused by medical management that prolonged the hospitalization, produced a disability at the time of discharge or both. NEJM 324:370, 1991
  8. 8. 0 1 2 3 < 1 month  impairment 1‐6 month  impairment Permanent  impairment Death  Deaths d/t  negligence Percent of hospitalizations Disability and deaths per hospitalization NEJM 324:370, 1991
  9. 9. “As health care and the system that delivers it become more complex, the opportunities for errors abound.” Institute of Medicine Report, 1999
  10. 10. Complexity in IVF lab ● Techniques – Egg freezing and thawing – Embryoscope/Eeva – PGD/PGS and Day 5/6 biopsies – PICSI, IMSI ● Tests and Treatments  – Sperm tests:  SDFA, HBA – Day 5/6 biopsies/transfers/freezing – PAR and male/male couples – Frozen egg donors and recipients – Cryo all cycles and ever increasing numbers of frozen embryos
  11. 11. Errors in ART ● “My lab doesn’t make mistakes” ● Tendency in medicine and our field to hide our mistakes ● Creates a sense that mistakes don’t happen ● Not true!
  12. 12. “This report describes a serious concern in health care that, if discussed at all, is discussed only behind closed doors.” Institute of Medicine Report, 1999
  13. 13. Nonconformance database ● In March, 2003, Boston IVF became certified to the ISO  9001:2000 quality standard  ● Standard requires documentation of errors – created and  currently maintain electronic database ● “non‐fulfillment of a requirement,” i.e. any problem, error  or deviation from protocol. ● Database audited annually to ensure that all records are  complete
  14. 14. ART lab errors ● Reviewed our nonconformance database between March,  2003 and November, 2013 – What errors are made? – How many errors? – How significant were the errors? – What was the cause?
  15. 15. Departments and procedures ● Phlebotomy/pre‐analytic procedures ● Endocrine ● Andrology – SA; IUI and IVF sperm preparation; sperm freezing and storage;  associated ID ● Embryology – All procedures including frozen embryo and egg storage; PGS/D;  Pt ID
  16. 16. Study period ● March, 2003 ‐ November, 2013 ● Total number of cycles = 31,715 – 25,764 egg retrievals – 5,951 thaw cycles ● 25,205 IUI sperm preparations  ● 20,994 Semen Analyses ● Procedures:  Semen analysis, Egg retrievals, Semen prep for  IUI/IVF/ICSI, ICSI and insemination, Embryo, egg and sperm  cryopreservation, Embryo biopsy, Embryo transfers ● Total of 156,276 procedures
  17. 17. Average number per year ● 2,417 retrievals • 558 thaw cycles • 2,364 IUI cycles • 1,969 SA • 14,660 procedures
  18. 18. Category Communication Inter‐departmental  communication problems Documents/records Incorrect or incomplete  documentation  Equipment and supplies Failure of a piece of  equipment, including  computers, or supply item. External A problem which occurred  outside of Boston IVF (e.g.  transport) Facilities A problem with infra‐ structure such as HVAC.
  19. 19. Category Human An error such as performing  a task outside of a  documented protocol or a  mistake or oversight which  was most likely the direct  result of a human action. Patient problem/complaint A problem with a specific  patient or a complaint from a  patient. QA/QC/PT/Statistical out‐of‐ range values A problem not directly  attributable to a specific  cause such as a transient  drop in fertilization or  pregnancy rates. 
  20. 20. Grading ● None/Minimal – Error or problem occurred, but fully correctable or no  measurable effect ● Moderate – Serious error which affects a cycle, but cycle not lost ● Significant – Significant compromise or loss of cycle
  21. 21. Grading ● Major – A pregnancy or birth confirmed to have arisen from a  misidentification of gametes or embryos  – Systemic  or repeated problems which significantly affect  multiple patients over a period of time – Serious and repeated deficiencies during FDA, CLIA, CAP or  State inspections ● To date, no major errors at Boston IVF 
  22. 22. Example of Major ● Expert review at lab “X” (since closed) – Reviewed all embryology and cryo records – 9.5% of cycles with significant documentation errors with  1.9% without embryologist “A” – Another 16.7% with minor errors – Many lawsuits and these are the only records!!
  23. 23. Number All Nonconformances Andrology/Embryology 374 Statistical/QA 81 All Graded Errors 293 None/Minimal 219 Moderate 58 Significant 16 Major 0
  24. 24. 0 10 20 30 40 50 60 70 80 90 100 None/ Minimal
  25. 25. 0 5 10 15 20 25 30 35 40 45 Moderate Significant
  26. 26. TYPE SEVERITY DESCRIPTION Human  None/Minimal When preparing to do an embryo transfer I  saw that the culture dish was properly  labeled, but the transfer dish was mislabeled  with an incorrect first name.  This dish had  the proper number of embryos in it at the  proper stages of development and the correct  last name and date of birth. 
  27. 27. TYPE SEVERITY DESCRIPTION Human Moderate “John” (a new embryologist) was handling the dishes of pt P during fertilization assessment. There were 14 oocytes in the  dish, 9 ICSIed and 5 inseminated.  The 8 ICSI ferts were  moved to the culture dish, but, before the remaining 5 eggs  were assessed for fertilization, the original dish was  accidently flipped over. 1 of the remaining oocytes was  found, but 4 were not recovered.
  28. 28. TYPE SEVERITY DESCRIPTION Equipment Significant I was using a 150um stripper tip to strip the eggs of pt R. I  individually picked up each egg from their original drops and  moved them through a wash drop and then to a culture drop.  When I expelled the media into the culture drop, no eggs  emerged. I examined the pipet under the microscope and  could see no eggs in it, but could see a particle of plastic lodged  in the tip. I flushed the pipet using a needle and syringe but still  found no eggs. The drop I had expelled the media into was  then re‐examined and 7 ruptured zonas could be seen.
  29. 29. Where are the errors made?
  30. 30. Number None /  Minimal  (%) Moderate (%) Significant (%) Andrology 31 29 (93.5) 2 (6.5) 0 (0.0) Cryo. /  Storage 39 24 (61.5) 12 (30.8) 3 (7.7) Embryology 67 38 (56.7) 25 (37.3) 4 (6.0) PGD 3 0 (0.0) 3 (100.0) 0 (0.0) TOTAL 140 91 42 7 Human Error
  31. 31. 0.0% 0.1% 0.2% 0.3% 0.4% 0.5% 0.6% 0.7% 0.8% Error rate per cycle
  32. 32. 4.8 0.5 0.3 0.0006 0 1 2 3 4 5 6 CAP study on  outpatient lab  requisition errors Clinical lab errors Transfusion errors BIVF  Phleb/Endocrine Percent How do our error rates compare? Clin Chem 48:691, 2002
  33. 33. 0.0% 0.1% 0.2% 0.3% 0.4% 0.5% 0.6% 0.7% 0.8% How do our error rates compare? Error rate per cycle Bird et al., P-001, Assoc of Clinical Embryologists, Leeds, UK, 2012
  34. 34. 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 HFEA A Severe HFEA B Significant HFEA C Moderate HFEA B&C Moderate and Significant BIVF Significant BIVF Moderate BIVF Moderate and Significant
  35. 35. Comparison Number 1 error per X  cycles Number of  years for clinic  with 400  cycles/yr Moderate 58 547 1.4 Moderate/Human 42 755 1.9 Significant 16 1982 5.0 Significant/Human 7 4530 11.3
  36. 36. Number of embryologists/andrologists Number of cycles ASRM (minimum #) High performing labs* 250 3 2 500 4 4 1000 6 8 1500 9 12 2000 11 16 3000 16 24 *Van Voorhis et al., Fert Steril 94:1346,2010
  37. 37. How are we doing? “U.S. health care organizations still have a ways to go to achieve a culture in which all errors are openly identified and investigated.” NEJM 369:1677, 2013, “Improving Patient Safety Through Transparency”
  38. 38. “…most importantly, we must systematically design safety into processes of care. Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing. Cars are designed so that drivers cannot start them while in reverse because that prevents accidents.” Institute of Medicine Report, 1999
  39. 39. Disclosure to Patients ● 2011 ASRM Ethics Committee Report ● “Clinics have an ethical obligation to disclose errors out of respect for patient autonomy and in fairness to patients.” ● Errors that affect the number of quality of embryos should be disclosed unless minimal impact ● Obligatory to disclose errors where gametes or embryos are switched ● Clinics should promote culture of truth-telling ● Should establish written procedures for disclosure ● Rigorous procedures for proper ID and prevention of loss
  40. 40. Disclosure ● Difficult – Hard to admit mistake has been made – Reputation – Legal fears – Blame focused on individual, not system ● Every situation unique ● Do we disclose every error or near-miss? ● Disclosure, Apology and Offer
  41. 41. “Culture of truth-telling” ● Within lab – Be upfront with embryologists about how errors are handled and possible consequences – Foster a culture of openness and honesty – Discuss in meetings ● Accountability – Must have fair and just procedure – No blame where the problem stems from the system – Proportionate blame where procedures were violated ● Lab and physicians should agree about how to handle errors
  42. 42. Procedures for identification ● Witnesses for every step – All SA and IUI specimens witnessed – Wristband checks for all egg retrievals and transfers – Time out prior to egg retrieval – At time of transfer, TV monitor displays pt. name and DOB on bottom of dish to pt., nurses and physician ● HFEA – witnessing requirement ● Electronic witnessing – Matcher – bar codes – RI Witness – RFID chips
  43. 43. How do we define Quality in ART? ● SART/CDC statistics ● Research ● Latest Technology ● PT and inspections ● Internally – QC and QM, errors – FR, PR etc.
  44. 44. Quality Management Systems ● What is a Quality Management System? ● What do you have in place at your clinic? ● Is it working well? ● Familiar with ISO?
  45. 45. ISO ● International Organization for Standardization ● Derived from Greek - isos - equal or standard ● NGO in 150 countries (including the USA) ● Established in 1947 to promote the development of standardization to facilitate trade
  46. 46. ISO definition of Quality “Degree to which a set of inherent characteristics fulfills requirements.”
  47. 47. Requirements and Characteristics ● Requirements: – Employees trained and competent – Adherence to established procedures – Good communication – Instruments functioning properly – Supplies appropriate and adequate ● Characteristics: how the organization fulfills the requirements
  48. 48. ISO 9001:2008 Summary ● One quality manager over entire system ● Documents and records are controlled, organized and available ● Equipment properly maintained ● Measurements of quality ● Audits (internal and external) ● Dealing effectively with problems
  49. 49. Summary ● 99.8% of cycles proceeded without error which affected cycle ● Errors are inevitable! ● We can ignore them or ● Use them to improve – Have procedures in place for handling them – Acknowledge them – Understand why they happened ‐ get to the source of the  problem – Opportunities to improve processes ● Quality Management System in place
  50. 50. Acknowledgements ● Drs. Denny Sakkas and Michael Alper for help with the Error Study ● All those who have been involved in the ISO Quality Program at Boston IVF

×