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Florida Clinical Laboratory Cancer Identification Program (CLIP) Update

Florida Clinical Laboratory Cancer Identification Program (CLIP) Update. FCDS 2002 Educational Teleconference Series http://fcds.med.miami.edu Mayra Alvarez, RHIT, CTR Mark Rudolph Gary Levin Steven Peace, CTR October 29, 2002. Laboratory Data Contribution. Case identification only

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Florida Clinical Laboratory Cancer Identification Program (CLIP) Update

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  1. Florida Clinical Laboratory Cancer Identification Program(CLIP) Update FCDS 2002 Educational Teleconference Series http://fcds.med.miami.edu Mayra Alvarez, RHIT, CTR Mark Rudolph Gary Levin Steven Peace, CTR October 29, 2002

  2. Laboratory Data Contribution • Case identification only • Match laboratory data against masterfile • Follow-back unmatched records to physician for abbreviated abstract Florida Clinical Laboratory Cancer Identification Program (CLIP)

  3. CLIP Program Announcements • February 8, 2002 - Program Announcement • Letter of Introduction - John O Agwunobi, MD. MBA, Florida Secretary of the Department of Health • Florida Cancer Reporting Legislation • Florida Department of Health Administrative Rules Florida Clinical Laboratory Cancer Identification Program (CLIP)

  4. CLIP Program Announcements • June 7, 2002 – Program Details from FCDS • Program Outline • Record Layout & File Format Specifications • DOH Program Announcement • Laboratory Information Verification Form • Teleconference Announcement Florida Clinical Laboratory Cancer Identification Program (CLIP)

  5. Florida Statutes Florida Statute 385.202 provides for the establishment of a statewide cancer registry. All facilities licensed under Florida Statute 395 and each freestanding radiation therapy center as defined in Florida Statute 408.07 shall report to the Department of Health, through FCDS, such cancer incidence information as specified by Rule 64D-3.006, which includes, but is not limited to, diagnosis, stage of disease, medical history, laboratory data, tissue diagnosis, radiation, or surgical treatment and either method of diagnosis or treatment for each cancer diagnosed or treated by the facility or center. Failure to comply with this requirement may cause for registration or licensure suspension or revocation. Any licensed practitioner in the state of Florida that practices medicine, osteopathic, chiropractic medicine, naturopathy or veterinary medicine are required to report under Florida Statue 381.0031 or any laboratory licensed under chapter Florida Statute 483 that diagnoses or suspects the existence of a disease of public health significance shall immediately report the fact to the Department of Health. Confidentiality FCDS continues to adhere to all Florida Statues and Department of Health guidelines regarding patient and institutional confidentiality. Immunity No institute or individual complying with Florida Statutes 385.202, 405.01, 381.0031, and Florida Administrative Code, Rules 64D-3.004 and 64D-3.006 shall be civilly or criminally liable for divulging information required by the law. Please visit the Florida Statutes for the latest revisions to the above statutes. Florida Statutes Florida Statute 385.202 provides for the establishment of a statewide cancer registry. All facilities licensed under Florida Statute 395 and each freestanding radiation therapy center as defined in Florida Statute 408.07 shall report to the Department of Health, through FCDS, such cancer incidence information as specified by Rule 64D-3.006, which includes, but is not limited to, diagnosis, stage of disease, medical history, laboratory data, tissue diagnosis, radiation, or surgical treatment and either method of diagnosis or treatment for each cancer diagnosed or treated by the facility or center. Failure to comply with this requirement may cause for registration or licensure suspension or revocation. Any licensed practitioner in the state of Florida that practices medicine, osteopathic, chiropractic medicine, naturopathy or veterinary medicine are required to report under Florida Statue 381.0031 or any laboratory licensed under chapter Florida Statute 483 that diagnoses or suspects the existence of a disease of public health significance shall immediately report the fact to the Department of Health. Confidentiality FCDS continues to adhere to all Florida Statues and Department of Health guidelines regarding patient and institutional confidentiality. Immunity No institute or individual complying with Florida Statutes 385.202, 405.01, 381.0031, and Florida Administrative Code, Rules 64D-3.004 and 64D-3.006 shall be civilly or criminally liable for divulging information required by the law. Please visit the Florida Statutes for the latest revisions to the above statutes. Florida Statutes & Legislation Florida Clinical Laboratory Cancer Identification Program (CLIP) Home Home | What's New | Welcome | Statistics | NewslettersQuestions | Staff | Links | Contact Us | Downloads | Law & Rules | Jobs | FCDS IDEADirect any comments or questions to Jill MacKinnon, Project Administrator. | What's New | Welcome | Statistics | NewslettersQuestions | Staff | Links | Contact Us | Downloads | Law & Rules | Jobs | FCDS IDEADirect any comments or questions to Jill MacKinnon, Project Administrator.

  6. Florida Statutes & Legislation Florida Clinical Laboratory Cancer Identification Program (CLIP)

  7. Why Start This Program Now ? Federal directive to “build capacity and infrastructure” for cancer and other disease surveillance programs in order to meet current and future needs and goals of these programs Florida Clinical Laboratory Cancer Identification Program (CLIP)

  8. Program Goals • Ensure 100% Cancer Case ID • Ensure 100% Cancer Case Reporting • Enhance Existing Case Records • Augment Coded Data Florida Clinical Laboratory Cancer Identification Program (CLIP)

  9. HIPAA & Cancer Reporting • Information Reported under “Public Health Authority” that is authorized by state law to be collected for the purposes of preventing or controlling disease...and to conduct public health surveillance...as part of official mandate is specifically exempt from the HIPAA Rules a a ‘covered entity’ which specifically makes allowances for reporting by physicians, clinical laboratories, in-patient and ambulatory patient care centers, state vital records and other covered entities. • FAQ’s about HIPAA & Cancer Reporting is available on the NAACCR website - http://www.naaccr.org Florida Clinical Laboratory Cancer Identification Program (CLIP)

  10. What About Confidentiality ? • Firewall between Web Server and Database • Secure Access to Files • Multiple Password Protection • Internet Data Encryption • Secure Internet Server • Secure Transportation • Secure Disposal • IRB Approval for Data Release • Annual Oath of Confidentiality Florida Clinical Laboratory Cancer Identification Program (CLIP)

  11. Labs – Who Must Report? • All Hospital-Based Labs • All Independent Labs • All Dermatopathology Labs • All Oral Pathology Labs • All Out of State Labs licensed to read Florida specimens under contract or other condition Florida Clinical Laboratory Cancer Identification Program (CLIP)

  12. My laboratory already works with a Cancer Registry. Do I still need to report? • Yes: Cancer case ID under the CLIP Program is a completely separate program from the existing hospital and ambulatory patient care facilities cancer case abstracting and reporting program • CLIP is an information systems case ID and reporting program, only • CLIP will not replace cancer registry reporting Florida Clinical Laboratory Cancer Identification Program (CLIP)

  13. Do I need to hire a cancer registrar to ID & report cases? NO ! Clinical Labs do not need to hire professional cancer registrars or contract cancer case abstractors to meet ANY of the FCDS cancer case identification or clinical lab reporting program requirements Florida Clinical Laboratory Cancer Identification Program (CLIP)

  14. Where do we to find the Path Lab information on the web? Florida Clinical Laboratory Cancer Identification Program (CLIP)

  15. Florida Clinical Laboratory Cancer Identification Program (CLIP)

  16. Test Cases • Test cases can be sent to FCDS to our programmer Mark on a floppy diskette by mail only OR • Use the test check box option on the upload page to automatically test your data Florida Clinical Laboratory Cancer Identification Program (CLIP)

  17. How Do We Report? Utilizing Web-based Software

  18. Click FCDS IDEA Florida Clinical Laboratory Cancer Identification Program (CLIP)

  19. Login Florida Clinical Laboratory Cancer Identification Program (CLIP)

  20. Enter FCDS Supplied Username and Password Florida Clinical Laboratory Cancer Identification Program (CLIP)

  21. Vendor Upload Florida Clinical Laboratory Cancer Identification Program (CLIP)

  22. Click Upload data file Florida Clinical Laboratory Cancer Identification Program (CLIP)

  23. Type in file name you Wish to upload. File created from your Vendor software Click if you want to TEST the upload Florida Clinical Laboratory Cancer Identification Program (CLIP)

  24. Florida Clinical Laboratory Cancer Identification Program (CLIP)

  25. Florida Clinical Laboratory Cancer Identification Program (CLIP)

  26. Florida Clinical Laboratory Cancer Identification Program (CLIP)

  27. Single Record Data Entry Florida Clinical Laboratory Cancer Identification Program (CLIP)

  28. Click Single Path Entry Florida Clinical Laboratory Cancer Identification Program (CLIP)

  29. Type in CLIA Number Information Will be Generated Florida Clinical Laboratory Cancer Identification Program (CLIP)

  30. Complete Entry Cut and paste from Your source document Into the text areas Florida Clinical Laboratory Cancer Identification Program (CLIP)

  31. Complete Entry and Click Submit Cut and paste from Your source document Into the text areas Florida Clinical Laboratory Cancer Identification Program (CLIP)

  32. Florida Clinical Laboratory Cancer Identification Program (CLIP)

  33. What Are Data Requirements? • Refer to Pathology Case Record Layout • Reporting Lab Information • Required Data Items • Optional Data Items • NAACCR Standard Data Dictionary, Path Version Florida Clinical Laboratory Cancer Identification Program (CLIP)

  34. Labs – What Must Be Reported? • All Histologically - Confirmed Cancers EXCLUDING BASAL AND SQUAMOUS CELL SKIN CANCERS • What is a Reportable Cancer ? • CDC and Florida DOH Definitions of Reportable Cancers • ref: ICD-O-3 behavior code of /2 (insitu) or /3 (malignant) • ref: 2001 FCDS Data Acquisition Manual - Section I Florida Clinical Laboratory Cancer Identification Program (CLIP)

  35. Labs – What Must Be Reported? • Case ID Procedures Must Include • surgical pathology - diagnosis or treatment • excisional or incisional biopsy • needle biopsy “cytology” • bone marrow biopsy • electron micrograph • other specialty • consultation • autopsy • other • DO NOT REPORT sputum, smears or other cytology Florida Clinical Laboratory Cancer Identification Program (CLIP)

  36. Labs – What Must Be Reported? • Negative tissue samples received from wide excisions, colectomy specimen, mastectomy or other surgical treatment of malignancy • Exclusions - DO NOT REPORT !! • Basal Cell Carcinoma of Skin (non-genital skin sites) • Squamous Cell Carcinoma of Skin (non-genital skin sites) • In situ carcinoma of the cervix (CIS), intraepithelial neoplasia grade III of the cervix (CIN III) and intraepithelial neoplasia of the prostate (PIN III) Florida Clinical Laboratory Cancer Identification Program (CLIP)

  37. 3 Options for in-House Case Identification • SNOMED Cancer Codes • ICD-9 Cancer Codes • Word and Word Combination File • NAACCR Standard has a 800 word string • Word/Word Combination List for Case ID • Proven Track Record • Excel File or PDF • Versatile Florida Clinical Laboratory Cancer Identification Program (CLIP)

  38. SNOMED Cancer Codes • SNOMED Morphology "axis“ code structure & codeset • M-xxxx with as many as 18 characters in the codestring • Select all cases with any Code M-8000 through M-9999 • Record Layout will allow up to 15 sets of SNOMED codes • SNOMED Site/Topography “axis” code structure • SNOMED uses T-xxx • Not useful to FCDS • May be useful for you • Mapping tables may be needed to convert data • Contact SNOMED for more information at http://www.snomed.org Florida Clinical Laboratory Cancer Identification Program (CLIP)

  39. ICD-9 Cancer Codes • ICD-9-CM Code(s) Diagnosis (in preferred ICD-O-3 terminology) • * 042 AIDS (review cases for AIDS-related malignancies) • * 140.0 - 208.9 Malignant neoplasms (1o, primary, and 2o, secondary) • * 230.0 - 234.9 Carcinoma in situ – all sites (exclude cervix – 233.1) • * 235.0 - 238.9 Neoplasms of uncertain behavior • * 236.0 Endometrial stroma, low grade (M8931/3), (236.0) • * 236.0 Endolymphatic stromal myosis, (M8931/3), (236.0) • * 236.0 Endometrial stromatosis, (M8931/3), (236.0) • * 236.0 Stromal Endometriosis, (M8931/3), (236.0) • * 236.0 Stromal myosis, NOS (M8931/3), (236.0) • * 237.5 Ependymoma (epithelial) (malignant) (M9391/3) papillary, (237.5) • * 237.6 Papillary Meningioma (M9538/3), (237.6) • * 238.4 Polycythemia (primary) (rubra) (vera) (M9950/3), (238.4) • * 238.6 Solitary plasmacytoma (M9731/3) • * 238.6 Extramedullary plasmacytoma (M9734/3) • * 238.7 Chronic myeloproliferative disease (M9960/3) • Continued… Florida Clinical Laboratory Cancer Identification Program (CLIP)

  40. ICD-9 Cancer Codes • Select cases with ICD-9 Code appearing in the list • * Case Required – ICD-9 cancer diagnosis code • + Case Optional – ICD-9 code indicates non-reportable cancer or patient with history of cancer, inactive disease or patient seen for follow-up • Data can include a combination of alpha and numeric characters • Data can include a decimal point for higher level specificity • Code can be up to 10 characters in length • Record Layout will allow up to 6 sets of ICD-9 Codes Florida Clinical Laboratory Cancer Identification Program (CLIP)

  41. NAACCR 800 Word Search File • Use this file to search the text areas of your word processing, spreadsheet or database report files where information from the final pathology report is stored • Includes all cancer & cancer-related terms • The listing over-selects some types of cancer cases as a normal part of operation, • Non-reportable cancers will be deleted from the database on visual review by FCDS • http://www.fcds.med.miami.edu or http://www.naaccr.org/Standards/pathlabcom.html Florida Clinical Laboratory Cancer Identification Program (CLIP)

  42. NAACCR 800 Word Search File • ADENOCARCINOMA • ADENOID SQUAMOUS CELL CARCINOMA • ADENOSQUAMOUS CARCINOMA • ADNEXAL CARCINOMA • ADRENAL CORTICAL CARCINOMA • ADULT T CELL LEUKEMIA • ADULT T CELL LYMPHOMA • AIN 23 • AIN 3 • AIN GRADE III • AIN III • ALEUKEMIC GRANULOCYTIC LEUKEMIA • ALEUKEMIC LEUKEMIA http://fcds.med.miami.edu/downloads/PathLab/ • Continued… Florida Clinical Laboratory Cancer Identification Program (CLIP)

  43. How Must Cases Be Submitted? • ASCII File (text file) • Tab Delimited • No Headers • No embedded CR/LF, TABS, Quote (“) or other control characters • Left Justified – Blank Filled • Dates in CCYYMMDD format • One CR/LF sequence at end of each record Florida Clinical Laboratory Cancer Identification Program (CLIP)

  44. CLIP - Deadlines • December 31, 2002 Deadline • Case Reports from January 2002 through June 2002 are DUE January 2003 - FCDS will contact all non-compliant labs • June 30, 2003 Deadline • Case Reports from July 2002 through December 2002 are DUE July 2003 - FCDS will contact all non-compliant labs • August 2003 - DOH will contact remaining non-compliant labs • October 2003 - AHCA division of licensing notified for non-compliance Florida Clinical Laboratory Cancer Identification Program (CLIP)

  45. Stay Informed • FCDS Website - http://www.fcds.med.miami.edu • Path Lab Program Announcement & Info Packet • Laboratory Information Verification Form • Teleconference slides & notes on FCDS website • FCDS Monthly Memo • FCDS Quarterly Newsletter • FCDS Teleconferences • FCDS Annual Conference • Call us @ 1-800-906-3034 Florida Clinical Laboratory Cancer Identification Program (CLIP)

  46. Useful Cancer-Related Websites • FCDS - http://www.fcds.med.miami.edu • CDC/NPCR - http://www.cdc.gov/cancer/npcr • NAACCR - http://www.naaccr.org • CAP - http://www.cap.org • SNOMED - http://www.snomed.org • NCI Main Cancer Info - http://cancer.gov • NCI/SEER - http://seer.cancer.gov • ACoS/COC - http://www.facs.org/dept/cancer • Florida DOH - http://www.doh.state.fl.us • Florida C-CRAB - http://www.moffitt.usf.edu/ccrab • Florida Legislature - http://www.leg.state.fl.us/Statutes Florida Clinical Laboratory Cancer Identification Program (CLIP)

  47. Acronyms • FCDS – Florida Cancer Data System • CDC/NPCR – Centers for Disease Control & Prevention/ National Program of Cancer Registries • NAACCR – North American Association of Central Cancer Registries • CAP – College of American Pathologists • SNOMED – Systemized Nomenclature of Medicine • NCI – National Cancer Institute • NCI/SEER – National Cancer Institute/ Surveillance, Epidemiology & End-Results Program • ACoS/COC – American College of Surgeons/ Commission on Cancer • Florida DOH – Florida Department of Health • C-CRAB – Florida Cancer Control & Research Advisory Council • Legislature – Our Elected Officials in Tallahassee Florida Clinical Laboratory Cancer Identification Program (CLIP)

  48. For Additional Information Contact Us Florida Cancer Data System University of Miami School of Medicine P.O. Box 016960 (D 4-11) Miami, Fl 33101 1-800-906-3034 Phone (305) 243-4600 Fax (305) 243-4871 http://fcds.med.miami.edu Florida Clinical Laboratory Cancer Identification Program (CLIP)

  49. THANK YOU ! Florida Clinical Laboratory Cancer Identification Program (CLIP)

  50. QUESTIONS ??? And now, Questions. We will be jotting down your questions, and will include them in the next FCDS Monthly Memo. All FCDS Teleconferences are valid for Continuing Education credit. A one hour teleconference equals one hour on your CE form. Also, we do have a list of all of the call in sites should you ever need a copy for Continuing Education Auditing purposes. Just contact us and we will send you a copy. TO ASK A QUESTION - Press 1 then 0 on your phone and you will be placed as the next caller. You will hear “You will be notified when the speaker/host is ready for your question”. Once the speaker is available to answer your question, you will hear “Please ask your question after the tone”. To Withdraw Your Question - After you enter 1 and 0, if you decide to withdraw your question, then just press 1 and 0 again. Florida Clinical Laboratory Cancer Identification Program (CLIP)

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