Participating In Selecting Laboratory Medicine: Second Opinion on Malignant Diagnosis or Misdiagnosis Presented by : Jackson L. Gates, MD, FCAP Medical director and associate pathologist Doctors Laboratory Inc. Valdosta, Georgia

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Participating In Selecting Laboratory
MedicineSecond Opinion on Malignant Diagnosis
or MisdiagnosisPresented by Jackson L.
Gates, MD, FCAPMedical director and associate
pathologistDoctors Laboratory Inc.Valdosta,
Georgia
Patients with Guidance of Physician
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ABOUT DLIhttp//www.doctorslabinc.com

• Annual test volume
• Approximately 8,000,000 laboratory
• tests
• Regional Reference Laboratory, Covering Georgia,
  Florida, and Alabama with well over 5,000 clients
  
• Accredited and Certified by Professional and
  Governing Authorities, including CAP, CLIA, etc.
• Staff Members include Board-certified
  pathologists, and Clinical Scientists (PhD, MS)
• Licensed to provide interstate commerce.

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• A picture may be worth a thousand words,..

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Classic Seminoma
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Prostate adenocarcinoma Gleason, 8(44)
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• But diagnostic pathologic digital images on
  Final Pathology Reports are Few

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• Silent voices of patients cry out, I know my
  doctor I respect my doctor I know of his/her
  capabilities, and even reputation among his
  peers and, I know that he/she is caring and
  compassionate about my medical care. But I dont
  know the doctor who diagnosed my childs
  neuroblastoma, or who diagnosed my husbands
  glioblastoma multiforme, or who diagnosed my
  sisters small cell lung cancer, or my fathers
  terminal prostate cancer. I dont even know the
  doctor who diagnosed my mothers breast cancer.
  The real problem is that I dont know if the
  diagnoses were accurate and made in a timely
  manner.

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Laboratory Errors and Patients Safety go hand in
hand

• Clinicians play guardian role for safe and
  effective medical care for their patients
• Hospitals and insurance companies determine who
  provide laboratory services for patients, through
  exclusionary contracts or preferred lab
  agreements.
• The duopoly national laboratories provided
  60-65 of all laboratory services, and patients
  and/or their doctors did not have an opportunity
  to choose the lab.
• Pathologists who read patients specimens are
  generally unknown to patients clinicians, other
  than what is written through the lab companies
  descriptions.
• Communications between patients clinicians and
  pathologists are next to NONEXISTENT

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• Negative biopsy result, positive clinical
  findings, i.e. rising PSA, increasing size of a
  firm palpable breast mass, or fungating tumor
  protruding out from cervical os, IS A REALITY
  THAT HAPPENS.
• Patient becomes victim of a false negative biopsy

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A REASON TO BE CONCERNED

• 50 OF FALSE NEGATIVE PAP CYTOLOGY DIAGNOSES
  WERE DUE TO INTERPRETATIVE ERRORS
• Dr. David B. Troxel, Medical Director of
  The
• Doctors Company, and past president of
• American Board of Pathology.

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COMMUNICATION

• When pathologists communicate more frequently
  with care providers, the quality of the
  pathologists work improves because both the
  clinician and the pathologist are better informed
  about the patients
• Dr. Stephen Raab

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EXAMPLES OF PATIENTS ACCESSING PUBLICLY AVAILABLE
MEDICAL INFORMATION
WSB-channel 2- Ask The Doctor Online-Ask the
Expert Commercials-Web MD
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Patients taking on Active RolesIn participation
of their Healthcare

• Access to easy to understand, simple language,
  medical information has become the norm
• Peer-reviewed medical information is now
  available in the media (i.e. TV, news,
  magazines), on the internet and through other
  public resources, THAT used to be found only in
  medical journals that physicians or scientists
  could only understand for the most part.

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LET ME ASK YOU

• Are all labs equal?
• Are all pathologists equal?
• Are there cover-ups for mistakes in the
  laboratory?
• How many times are selections of which laboratory
  provide services are based on cost alone rather
  than quality i.e. reproducible accuracy, turn
  around time, and willingness to provide direct
  communication?

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Hot topic from G2 Reports onImproving
Pathology Practice by Examining and Reducing
Errors

• Some of the most devastating medical errors for
  patients can start in the lab ranging from a
  biopsy that doesnt extract the tumor cells to a
  mix-up with another patients sample.
• 3-5 of the billions of annual U.S. lab
  specimens defective, but the more worrisome
  problem is the higher and more dangerous error
  rate of certain tests where, for example, a false
  positive may result in unnecessary surgery..
• 
  Washington G2
• 
  Report
• 
  February 22,2006

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Objective

• To show the value of SECOND OPINION in laboratory
  medicine particularly with regards to Anatomic
  Pathology.
• How important for Patients to participate in
  their healthcare with regards to laboratory
  diagnoses.
• To illustrate through selected cases, the
  importance of effective communication between
  pathologist and patients clinician
• To discuss the significance of laboratory errors
  in patient care, and what can be done and is
  being done to standardize medical laboratory
  practices.

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Selected Cases From My Experience

• Cystic Ovarian tumor in 16 year old
• A tumor of the Appendix
• Prostate Biopsy
• Colonic Polyp
• Cystic Tumor of the Ovary, and Consult Letter
  from Expert
• Cervical Neoplasia in the Young

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My initial Experience On Second Opinion
Pathology Interpretation

• My brother-in-law frantic request for second
  Opinion
• Small Colonic Biopsy
• Histiocytic cells in lamina propria
• S100 Positive
• Recommended Repeat Biopsy with Follow-up
  Colonoscopy by primary reviewing pathologist
• Second opinion by two other (2) board-certified
  pathologists could not confirm neoplasia.

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• This second opinion consultation saved my
  brother-in law at least 2,000 in medical
  expenses.
• But more than that, it gave him a piece of mind
  to know that he did not have a pre-malignant or
  malignant condition.

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CASE 1

• A sixteen (16) year old African American female
  presented with an ovarian mass, and underwent a
  salpingo-oophorectomy. A relatively large
  ovarian mass was received in the laboratory
  measuring 14 cm. in maximum diameter and was
  grossly described by the original
  pathologist-gross examiner, as being cystic-solid
  with areas of necrosis and hemorrhage.

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CASE 1 (continues)

• Microscopic sections showed features of dermoid
  cyst (mature cystic teratoma) at the time of
  review by the original pathologist, a bright
  young surgical pathologist with dual fellowship
  training in cytopathology and surgical pathology
  from MD-Anderson.

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CASE 1 (continues)

• Approximately two(2) months later, the patient
  presented to the hospital with extensive tumor
  involvement of her abdomen. She underwent tumor
  debulking, and chemotherapeutic rescue. A review
  of her previous original oophorectomy specimen
  revealed immature neural elements (features of
  malignant, immature cystic teratoma, which was
  reflected in the revised pathology report.

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• In the next few cases which are taken directly
  from my own practice-case repertoire, I will
  illustrate just how difficult some cases can be,
  and show appropriate ways of getting to the best
  and most accurate diagnosis for the sake of
  minimizing error and considering patient safety.
  In these examples, in addition to communication
  with patients clinician and clinico-pathologic
  correlation, immunostains are illustrated and
  expert or second opinions are presented to show
  incorporation of other pathologists in efforts to
  achieve a more accurate diagnosis.

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CASE 2

• A 25 year old African American male presented
  with an acute abdomen. A CT scan was performed
  and the patient was taken to surgery, where he
  underwent an appendectomy for CLINICALLY suspect
  acute appendicitis. At the time of surgery,
  evidence of neoplasm and/or carcinoid syndrome
  was clinically absent.
• Received was a vermiform glistening appendix with
  attached periappendiceal adipose tissue,
  measuring 7 cm in length by 1.5 cm in width. A
  white fibrous tumor was noted in the tip of the
  appendix measuring 1.3 x 1.2 cm in maximum
  dimensions, grossly just extending into the
  serosal adipose tissue. Necrosis or hemorrhage
  was absent.

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CASE 2 (continues)

• MICROSCOPIC
• Infiltrating tubulo-glandular tumor cells
  present in dense
• fibrous stroma, with moderate
• nuclear pleomorphism, including some cells
  showing
• vesicular nuclei with prominent
  macronuceloli.
• Mitotic figures were infrequent
• Necrosis was absent
• Goblet cell formation was absent.
• The tumor extended to just into serosal
  adipose tissue but not
• into mesoappendix margins clear.
• IMMUNOSTAINS Chromogrannin (-)
  synaptophysin
• () Neuron specific enolase (NSE) ()
• pancytokeratin () Mucin (negative)

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CASE 2 (continues)

• Differential Diagnosis
• Primary Adenocarcinoma of Appendix
• Metastatic Adenocarcinoma, NOS
• Carcinoid
• Goblet cell
  carcinoid
• Malignant
  Carcinoid

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CASE 2 (continues)

• DIAGNOSIS
• Glandular Carcinoid

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CASE 3

• A 57 year old African American male presented
  with rising PSA levels.
• Received multiple needle core biopsies of
  prostate tissue ranging in size from 1.2 to 1.6
  cm in length

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CASE 3 (continues)

• DIAGNOSIS
• ADENOCARCINOMA, GLEASON SCORE 7 (43), 1 OF
  BIOPSY SAMPLE

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CASE 4

• A 76 year old African American female presented
  with rectal bleeding, and a colonoscopy revealed
  a polyp in the cecal colon.
• A biopsy of this polyp was submitted.

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CASE 4 (continues)

• DIAGNOSIS
• SEVERE DYSPLASIA VERSUS INTRAMUCOSAL
  COLONIC ADENOCARCINOMA ARISING WITHIN A
  BACKGROUND OF TUBULOVILLOUS ADENOMATOUS POLYP

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CASE 5

• A 25 year old African American female presented
  with an adnexal mass, and underwent a
  salpingo-oophorectomy
• An approximately 40 pound cystic solid ovary was
  received (see gross photograph)
• A frozen section diagnosis was requested

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CASE 5

• A 25 year old African American female presented
  with an adnexal mass, and underwent a
  salpingo-oophorectomy
• An approximately 40 pound cystic solid ovary was
  received (see gross photograph)
• A frozen section diagnosis was requested

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CASE 5 (continues)

• Frozen Section Diagnosis
• Mucinous cyst-adenoma with at least
• borderline features

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CASE 5 (continues)

• LETTER FROM EXPERT CONSULTANT

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CASE 6

• A 22 year old African American female
  underwent a cone biopsy after follow-up HSIL pap
  with biopsies showed Severe squamous dysplasia

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CASE 6 (continues)

• DIAGNOSIS
• Severe squamous dysplasia/Carcinoma in-Situ
• with features strongly suspicious for
  micro-invasion

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• DISCUSSION
• to err is human
• Leape and Berwick, The IOM Report

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• If it doesnt fit, you must acquit.
• JOHNNIE COCHRAN

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• If it doesnt fit the clinical story, you must
  request a SECOND OPINION

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• ACCURACY
• INCREASES
• WITH INCREASING NUMBERS OF OPINION IN LABORATORY
  MEDICINE
• Particularly in Anatomic Pathology

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• Nationwide, an estimated 50-60 million errors
  will be made in the clinical laboratory
• Anatomic pathology accounts for an estimated 1.4
  to as much as 30 errors in certain pathology
  specialties like prostate and breast, and
  cytology (i.e. FNA, and Pap smears)
• The exact error rate depends on the laboratory
  institution
• Harvard and Hopkins are examples of
  institutions that have adapted QA policies that
  specify a percentage of all cancers are secondly
  reviewed within their pathology practices.

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• REASONS FOR ERRORS IN ANATOMIC PATHOLOGY
• A. Mislabeled specimens
• B. Inadequate specimen sampling
• C. Misinterpretation by pathologist
• D. Failure to adequately communicate
• pathologic findings, by pathologist

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ERRORS IN CLINICAL PATHOLOGY

• Mislabeled specimens
• Improperly collected specimens
• Suboptimal method of testing
• Medical technologists error
• Suboptimal QA/QC program
• Failed delta check program

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HOW TO MINIMIZE ERRORS IN LABORATORY MEDICINE

• OUR APPROACH AT DLI
• LIMITED HANDS ON
• 1. All specimens receive a barcode at TIME
• of specimen collection, with unique
• identifier.
• 2. VSII system tube of blood with
• barcode sample serum or
• plasma aliquots selected and submitted
• to respective sub-clinical laboratory
  divisions

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MINIMIZING LABORATORY ERRORS (continues)

• 3. Final results are verified by either
  two
• medical laboratory technologists and/
• or supervisors
• 4. Pathology-all prostate biopsies, and
• true cut breast, liver biopsies, ASC-H or
  HSILs are
• examples of double sign-outs
• 5. Diagnostic images are illustrated
• on web-based digital, final anatomic
  pathology report
• 6. Auto Imaging system(THIN PREP) in Pap
• cytology/Liquid Base
• 7. Consultations All unique or rare diagnoses
• are reviewed by other pathologists within
  the group
• or sent to nationally respected expert
  consultant for
• SECOND OPINION.

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Pathology Practice and Standards

• To achieve standardization, the pathologists in
  the practice must work together as a group and
  apply certain methods to improve quality.
• Dr. Stephen Raab

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More Eyes are better than TWO
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The Big Dog

• At many institutions, there is a dominant senior
  pathologist, the Big Dog, who becomes the gold
  standard of the anatomic pathology.
• Dr. Stephen
  Raab

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THE PROBLEM WITH CURRENT PATHOLOGY PRACTICE
SETTING

• I. An Honor Code System
• a. Hospital-based pathologist(s) make(s)
• the interpretation, and treatment is
• rendered without second opinion
• b. Commercial Lab-based pathologist(s)
• unknown to patients clinical doctor,
• creating lack of peer review quality
• assurance.

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PROBLEM (continues)

• II. Fear of pathology group(s) about legal
  liability or discovery of lack of quality or
  competence through external quality assurance
  evaluation.

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Suggested Solutions

• I. National Databank System to track pathologists
  who make errors, and who are involved in
  deception, cover-up, or fraud and abuse.
• II. External Review as apart of Quality
  Assurance
• III. Telepathology Monitoring Scheme
• encouraging Education and Communicable
  relationships among outside pathology groups.

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Good Generalist Effective Communication Know
when to seek SECOND OPINION
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Now, the solo-generalist can share
The power of Telepathology
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FUTURE OF DIAGNOSTIC LABORATORY MEDICINE

• MOLECULAR PATHOLOGY
• NANOTECHNOLOGY

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• CONCLUSION

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A PRICE TO PAY

• In 2005, this country spent an estimated 25 of
  its earnings on healthcare, more than some
  countries GNP.
• It has been estimated, 46 billion dollars were
  paid to laboratories across America.
• Therefore, we as patients and clinical
  practitioners should expect nothing less than the
  best care thats humanly possible

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If there is room for IMPROVEMENT,.

• So Be It.
• No ones perfect, but we should do everything
  possible within our might to assure a rate of
  laboratory error near the 0-1 for ALL PATHOLOGY
  PRACTICES
• All parties must be willing to work together to
  achieve this effort.

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• Laboratory Medicine, if not the gateway, is
  surely a bolt in the gate that assures quality
  and accuracy in healthcare as it relates to
  medical diagnosis of disease.
• It isnt enough to play the blame-game THAT
  LAB BECAUSE THE PATIENT IS THE ULTIMATE VICTIM,
  and cries out, What about me and my injuries or
  losses because of lack of quality care.

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• There are intense efforts to bring more rigorous
  standards to pathology labs, as highlighted by
  the G2 report.

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• Patients in this authors opinion, should get on
  board and request second opinion, particularly
  when final pathologic diagnostic decisions will
  affect the patients choices in life, be they
  treatment or management of disease.

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Our future depends on Quality and Safe Laboratory
Medical Practice
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REFERENCES

• Errors in Anatomic Pathology An interview with
  Dr. Stephen Raab.
• Laboratory Errors Patient Safety
  Vol. 3, issue 2, September
• October, 2006
• Knowledge and Perception of Colorectal Cancer
  Screening in Urban
• African AmericansGreiner, KA,
  et.al J.Gen. Internal Medicine, 2005
• November 20(11)977-983.
• SECOND OPINION HOW TO PREVENT THE COLLAPSE OF
  AMERICAS HEALTHCARE. Dr. Arnold Relman
• The G2 Report Improving Pathology Practice By
  Examining and Reducing Errors Audio Visual
  Conference, February 22.2006
• Health Should you Get a Second Opinion Lauren
  Picker http//www.lifetimetv.com
• Second Opinion in Diagnostic Anatomic
  Pathology A public consensus conference in
  Washington DC American Journal of Clinical
  Pathology, 2000.
• Mandatory second opinion surgical pathology at a
  larger referral hospital Kronz,JD, et.al
  Cancer. 1999862426-2435.
• The surgical pathology report as an educational
  tool for cancer patients. Strobel,S,et.al
  Annals of Clinical and Laboratory Science(2002)
  32363-368
• Exploring Nanotechnology in Cancer
  http//nano.cancer.gov