Patients with Guidance of Physician

1. Patients with Guidance of Physician Participating In Selecting Laboratory Medicine:Second Opinion on Malignant Diagnosis or MisdiagnosisPresented by :Jackson L. Gates, MD, FCAPMedical director and associate pathologistDoctors Laboratory Inc.Valdosta, Georgia

4. 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.

5. A picture may be worth a thousand words,…..

6. Classic Seminoma

7. Prostate adenocarcinoma Gleason, 8(4+4)

8. But diagnostic pathologic digital images on Final Pathology Reports are Few

9. 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 don’t know ‘the doctor’ who diagnosed my child’s neuroblastoma, or who diagnosed my husband’s glioblastoma multiforme, or who diagnosed my sister’s small cell lung cancer, or my father’s terminal prostate cancer. I don’t even know ‘the doctor’ who diagnosed my mother’s breast cancer. The real problem is that I don’t know if the diagnoses were accurate and made in a timely manner.”

10. 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

11. 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

16. 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.

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

18. EXAMPLES OF PATIENTS ACCESSING PUBLICLY AVAILABLE MEDICAL INFORMATION WSB-channel 2- “Ask The Doctor” Online-”Ask the Expert” Commercials-”Web MD”

19. 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.

20. 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?

21. “Hot” topic from G2 Reports on:“Improving 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 doesn’t extract the tumor cells to a mix-up with another patient’s 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

22. 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 patient’s 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.

23. 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

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. 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 patient’s 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.

30. 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.

31. 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)

41. CASE 2 (continues) Differential Diagnosis: Primary Adenocarcinoma of Appendix Metastatic Adenocarcinoma, NOS Carcinoid Goblet cell carcinoid Malignant Carcinoid

42. CASE 2 (continues) DIAGNOSIS Glandular Carcinoid

43. 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

47. CASE 3 (continues) DIAGNOSIS ADENOCARCINOMA, GLEASON SCORE 7 (4+3), 1 % OF BIOPSY SAMPLE

48. 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.