Practical Guide to Specimen Handling in Surgical Pathology Authors: Robert Lott, Janet Tunnicliffe, Elizabeth Sheppard, Jerry Santiago, Christa Hladik, Mansoor Nasim, Konnie Zeitner, Thomas Haas, Shane Kohl, Saeid Movahedi-Lankarani Practical Guide to Specimen Handling in Surgical Pathology Authors: Robert Lott, Janet Tunnicliffe, Elizabeth Sheppard, Jerry Santiago, Christa Hladik, Mansoor Nasim, Konnie Zeitner, Thomas Haas, Shane Kohl, Saeid Movahedi-Lankarani INTRODUCTION In spite of the abundant guidelines and recommendations published for specimen handling and testing in a clinical pathology laboratory, relatively little literature is available for guidance of specimen handling in a surgical pathology laboratory. This document does not relate to cytologic or clinical pathology samples. The following comprehensive table is intended to serve as a general guideline for proper specimen handling from the time it is taken from the patient to the time a completed slide of the specimen is given to a pathologist for interpretation. DISCLAIMER: This document was created by members of the CAP/NSH Histotechnology Committee and is intended to serve as a guideline ONLY and NOT AN absolute recommendation for specimen handling. Each laboratory is advised to use these guidelines as a starting point and modify certain parameters to fit state and local institutional requirements, as appropriate. Regulatory references, standards, and CAP checklist items cited in the guideline are current at the time of publication of this version of the guideline. It is recommended that the user confirm all references used are the latest version available. The use of the information contained in this guideline does not guarantee compliance with the CAP accreditation requirements or regulations from other accrediting organizations. Some information may be different or more stringent than the published CAP Checklists. It is the intent of the CAP/NSH Histotechnology Committee to update this document every 2 years or when required and have the updated version of the document available to members on the College of American Pathologists (CAP) and National Society for Histotechnology (NSH) websites. 1 Version:8.0 Revised: September,2018 Table of Contents: Part I – Specimen Collection and Handling Collection and Handling A. Patient Identification pg. 3 B. Proper Labeling pg. 3 C. Transport Media pg. 5 D. Completion of Requisition pg. 6 E. Recommendations for Tissue Collection and Handling pg. 11 F. Accessioning pg. 18 G. Handling prior to Gross Examination pg. 18 H. Intra-operative Consultation pg. 20 Part II – Laboratory Processes A. Guidelines pg. 24 B. Tissue Cassette Identification pg. 28 C. Fixation Parameters pg. 29 D. Processing pg. 33 E. Embedding pg. 37 F. Microtomy pg. 38 G. Staining pg. 42 H. Coverslipping pg. 52 2 Version:8.0 Revised: September,2018 VERSION REVISION DATE REVISION 1. Addition of disclaimer on cover page 2.0 November , 2013 2. addition of version control 3.0 November , 2014 1. Revised per comments received from CAP Chair review 1. Updated references – CAP Checklists: ANP, COM, GEN , 4-21-2014 2. All references reviewed 4.0 January, 2015 3. Table of contents added 5.0 September, 2015 1. Updated to reflect LAP Committee 2015 Checklist changes 6.0 November, 2015 1. Updated to reflect corrected formalin solution to tissue ratio with references 7.0 September, 2017 1. Updated to reflect August 21, 2017 CAP Checklist edition changes 1. Updated to reflect August 22, 2018 CAP Checklist edition changes 8.0 September, 2018 2. Updated to reflect review of all references 3 Version:8.0 Revised: September,2018 PART I I. SPECIMEN COLLECTION and HANDLING Related CAP Checklist Requirements Guideline Section Statement 2018 Edition Additional References Collection and Handling A. Patient Identification Patient is to be identified in a manner that respects patient privacy with respect to Laboratory General Checklist, GEN.41303 - their medical records and medical data. Patient Confidentiality Laboratory General Checklist, GEN.40490 - Patient Identification Patient's identity must be verified at the time of specimen collection. Laboratory General Checklist, GEN.40491 Primary Specimen Container Labeling Health Insurance and Portability and At least two acceptable unique identifiers are required for patient identification: Accountability Act (HIPAA). o Full name o Assigned identification number e.g. health record / master index number Clinical Laboratory Standards Institute o Date of birth CLSI - GP33A, Accuracy in Patient and o Photo on government issued or other photo ID card, such as driver's license Sample Identification; 2011: Vol. 30 o Other specific personal identifiers No7. International Standard ISO 15189:2012 - Medical Laboratories; section 5.4 - Pre-examination Processes Collection and Handling B. Proper Labelling Specimen is labeled in the presence of the patient Laboratory General Checklist, GEN.40490 – Patient Identification Specimen label must contain at least two unique identifiers: o Full patient name Laboratory General Checklist, GEN. 40100 - o Assigned identification number e.g. health record / master index number Specimen Collection Manual Elements o Date of Birth Customizable label elements – additional identifiers that are acceptable: Laboratory General Checklist, GEN. 40491 - Primary Specimen Container Labeling o Patient gender o Accession or requisition number o Ordering physician o Source of specimen ( e.g. skin) o Site of specimen ( e.g. left side of chest) 4 Version:8.0 Revised: September,2018 Clinical Laboratory Standards Institute CLSI – Auto12-A Specimen Labels: Content and Location, Fonts and Label Standardized format for label information should be implemented. All Common Checklist, COM.06100 – Orientation: 2011: Vol. 31 No7. o Last name, first name Primary Specimen Container Labeling o Date of Birth – DD –MMM- YYYY i.e. 12 MAR 1968 o Gender M, F, U ( unknown), T ( Transgender), I (Intersex) All Common Checklist, COM.06200 - Clinical Laboratory Standards Institute Secondary Specimen Container Labeling CLSI– Auto12-A Specimen Labels: Written documentation developed for the correct positioning of the label on the Content and Location, Fonts and Label collection container. Orientation: 2011: Vol. 31 No7. o Do not attach label to the container lid (in whole or part) Laboratory General Checklist, GEN.40492 – o Do not overlap label resulting in patient data being covered Specimen Label Correction Written documentation for the correction of labelling errors – to be followed when Laboratory General Checklist, GEN.40825 - specimens cannot be replaced Specimen ID Laboratory General Checklist, GEN.40491 - All subsequent labelling of patient samples (blocks and slides) must follow same Primary Specimen Container Labeling unique identifying process. Submitted slides may be labeled with a single identifier but two are preferred. Collection and Handling B. Proper Labelling All parameters used for standard specimen labelling are to be followed. Laboratory General Checklist, GEN.40825 - Zarbo RJ, Tuthill JM, D’Angelo R, et al. i. Barcoding and/or Specimen ID The Henry Ford Production System: Radio Frequency The unique specimen bar code or RFID label must be consistent across all reduction of surgical pathology in- Identification applications: specimen container, requisition label, cassette and slide labels. process misidentification defects by bar (RFID) code-specified work process Barcode and RIFD specifications within a failure rate established by your facility standardization. Am J Clin Pathol. 2009; for patient care. 131:469-477. Barcode label stock or RFID chip validated to withstand chemicals and Clinical Laboratory Standards Institute processing used for anatomic pathology specimens. CSLI – Auto02-A2 Laboratory Automation: Bar Codes for Specimen Bar coding and/or RFID documentation must be validated and maintained. Container Identification: 2006: Vol. 25 No 29. Automatic identification scanning equipment is validated for accuracy and resistant to chemicals used for anatomic pathology handing. 5 Version:8.0 Revised: September,2018 If used for specimen chain of custody tracking, the barcode or RFID tracking system must have intelligent location capabilities. Collection and Handling C. Transport Media Collection, handling and submission procedures must be made available to all Laboratory General Checklist, GEN.40100 - Clinical Laboratory Standards Institute i. No media / saline health care workers involved in the collection, labeling, submission and transport Specimen Collection Manual Elements CLSI – GP33A, Accuracy in Patient and of specimens to the pathology laboratory. Sample Identification; 2011: Vol 30 No7. Laboratory General Checklist, GEN.40125 – Handling of Referred Specimens Clinical Laboratory Standards Institute All specimens must be placed in leak proof container. CLSI - LIS09A, Standard guideline for Laboratory General Checklist, GEN.40511 - coordination of clinical laboratory Specimens should be transported to the laboratory immediately after collection. Specimen Tracking/Labeling services within electronic health record environment and networked Laboratory General Checklist, GEN.40535 - architectures; 2003: Vol. 23 No 15. Specimens that cannot be immediately transferred must be refrigerated until Specimen Transport QM transferred to the Pathology laboratory. International Standard ISO 15189:2007 For specimens submitted to the laboratory from remote sites, there is a - Medical Laboratories; section