!"##$% $&"'&()*+,-,./+&0&123%$"/+&"'&1.+4.5-)$6./& 7.8"3.5"3*&92.#,5*& :++23./-$&(3"%3.;& <2,= $#,/$+&'"3 & 7.8 "3.5"3*&( 3 5,-$& General' Anatomic'Pathology' Chemistry' Hematology' Transfusion'Medicine& '' 2012'Ed ition' ' Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/&& (.%$&@& GUIDELI NES'FOR'LABORATORY'PRACTIC E'‐'2012' SUMMARY'OF'LA BORATORY'GUIDELINES'CHANGES' ' The'following'GUIDELINES'have'been'revised,'added,'o r'deleted'in'this'edition' of'the'document.' ' REVISED:' Per formance'of'Whole'Blood'Gluc ose'Testing' Urinalysis' Retent ion'Guideline' Differential'Performanc e'&'Ref erral'Practice'Guideline' ' ' ADDED:' Reference 'Textbook'List ' Indirect'Platelet'Count' Procedure'for'Platelet'Estimate' Establishing'Conversion 'Factor'for'PLT'Estimation' Procedure'for'WBC'Estimate' Establishing'Conversion 'Factor'for'WBC'E stimati on' Protocol'for'Validation'of'Linearity'on'Automated'Hematolog y'Analyzers' ' ' DELETED:' Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/&& (.%$&>& Table of Contents ! General! 4' ' Retention'Guideline'' 5' ' Reference'Textbook'List' 8' ' Anatomic!Pathology! 10! ' Specimens'Exem pt'from'all'Gross'&/or'Microscopic'Pathology'Labor atories' 11' ' Surgical'Pathology'Reports' 13' ' Remova l'of'Tissu e,'Bl ocks'or'Slides'from'the'Original'Hospital'Site' 14' ' Perf ormance'of'Non‐Gynecological'Cytology' 16' ' Follow‐up'Reports'for'Gynecological'Cytology' 17' ' Follow‐up'Program'for'Cytology' 18' ' Chemistry! 19! ' Estimated'Glomerular'Filtration'Rate'–'eGFR' 20' ' Cholesterol/ Triglyceride/Lipid'Testing' 21' ' Urinalysis' 22' ' Rep orting'Sperm'in'Urine' 22' ' Quality'Control' 23' ' Perf ormance'of'Whole'Blood' Gluc ose'Testi ng' 24' ' Diagnosis'and'M onitoring'of'Thyroid'Disease' 26' ' Presence'of'Small'Amounts'of'Albumin' 29' ' Crosscheck/Validation'Guideline'for'T hose'Facilities'with'Multiple'C hemistry'Instruments' 30' ' Procedure/Method'Statis tical'Work‐up/Va lidation'Study'Guidelines' 31' ' Hematology! 33! ' Prin ciples'for'Hematology'Practice' 34' ' Hematology'Films/Labelling'of'Slides' 35' ' Morphology'of'Lymp hocytes' 36' ' Differen tial'Performance'and'Referral'Practice'Guideline' 38' ' Red 'Blood'Cell'Morpholo gy'Repor ting'Guideline' 40' ' Differen tial'Quality'C ontrol' 42' ' Smudge 'Cells' 45' ' Flow'Cytometry'for'the'Diagnosis'of'Lymphoma/Leukemia' 46' ' Mal aria' 47' ' Erythrocyte'Sedimentation'Rate'(ESR)' 48' ' D‐dimer ' 49' ' 3.2%'Na 'Citrate'Anticoagulant'Rec ommended'vs.'3. 8%'for'Coagulation'St udies' 53' ' Vitamin'B12'&'Folate' 54' ' Bleeding'Time' 56' ' Semen/Sper m'Analysis' 57' ' Crosscheck'Valid ation'Gu ideli ne'for'Facilities'with'Multiple' Hematology'Instruments' 58' ' Procedure/Method'Statis tical'Work‐up/Va lidation'Study'Guidelines' 59' ' Protocol'for' Validation'of'Linearity'on'Automated'Hematology'Analyzers '' 61' ' Procedure'for'WBC'Estimate' 64' ' ' Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/&& (.%$&B& ' ' ' Establishing'Con version'Factor'for'WB C'Estimation' 66' ' Procedure'for'Platele t'Estimat es' 68' ' Establishing' Conversion'F acto r'for'PLT'Estimation' 70' ' Indi rect' Platelet'Count' 72' ' ' ' Transfusion!Medicine! 74! ' Retention'of'Transfusion'Medicine'Re cord s' 75' ' Procedure/Method'Statistical'Vali dation/Work ‐up'Guidelines'–'Trans.'Med.' 76' ! Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/&& (.%$&C& GENERAL Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/&& (.%$&D& RETENTION GUIDELINE Laboratories vary in size, facility and extent of services provided. Clinical laboratories must maintain thorough, accessible records that can demonstrate an acceptable standard of care and compliance with the accreditation requirements. The Laboratory Quality Assurance Program of the College of Physicians and Surgeons urges laboratories to retain records, materials, or both for a longer period of time than specified for educational and quality improvement needs. Laboratories must establish policies that meet or exceed the following minimum requirements for retention of documents and specimens as established by professional and/or regulatory organizations. References include: CSTM, CSCC, CAP, CSA, ISO, CPSS Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/&& (.%$&E& Record Retention Storage Time Hematology Biochemistry Microbiology Cyto- pathology Surgical Pathology Accession record 1 year 1 year 1 year 2 years 2 years Worksheets 1 year 1 year 1 year 6 months 6 months Instrument print-outs 1 year 1 year 1 year n/a n/a Paper copy of patient reports 3 months 3 months 3 months indefinite indefinite Quality control/PT documents 2 years 2 years 2 years 2 years 2 years Maintenance records 2 years 2 years 2 years Life of the instrument, plus 2 years Service records Life of the instrument, plus 2 years Method /instrument evaluation 2 years after the method has been discontinued Procedure Manual 2 years after procedure has been discontinued Technologist ID & initials log/computer 1 year 1 year 1 year 1 year 1 year Telephone logs 3 months 3 months 3 months 3 months 3 months Requisition 3 months 3 months 1 year 5 years 5 years Laboratory Information Systems Records - Validation records, including transmission of results and calculations - Database changes - Hardware and software modifications - LIS downtime and corrective action 2 years 2 years 2 years 2 years 2 years Biomedical Waste Manifests must be retained for a minimum of 1 year Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/&& (.%$&F& Specimen Retention Hematology Chemistry Microbiology Cytopathology Surgical Pathology Peripheral Blood Smear -7days Peripheral Blood Smear reviewed by a pathologist -1 yr Semen smears - 3 months Bone Marrow Slides/Reports - 20 yrs (adults) - 50 yrs (children) Whole blood/Plasma - 24 hrs after report has been finalized Body fluids - 48 hrs after report has been finalized Urine - 24 hrs after report has been finalized Whole blood, serum & plasma - 48 hrs after report has been finalized Body fluids - 48 hrs after report has been finalized Urine - routine - 24 hrs after report has been finalized 24hr Urines - samples discarded 48 hrs after report has been finalized Swabs or specimens - 24 hrs after report has been finalized Positive Blood Culture - 5 days after reporting Gram Stain - one week or until final report is sent Ova & Parasite slides - one month Slides neg/unsatisfactory - 5 years Slides suspicious/pos - 20 years Fine-needle aspiration slides - 20 years Cytology Consultation/ Requisition - Indefinitely Male fertility slides - 1 year Cytology paraffin blocks - 20 years Blocks & slides - 20 yrs (adults) - 50 yrs (children) Autopsy - 20 yrs Gross specimen - min. 8 weeks after issue of report Wet Autopsy Tissue - 8 weeks after issue of report Bone Marrow Slides/ Reports - 20 yrs (adults) - 50 yrs (children) Photographic Transparencies – indexed and kept indefinitely Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/& (.%$&G& & REFERENCE TEXTBOOK LIST Microbiology 1) Manual of Clinical Microbiology 10 th Edition; American Society for Microbiology; Murray, Patrick R. 2) Bailey & Scott's Diagnostic Microbiology 12 th Edition, Mosby, Inc.; Forbes, Betty A., et al. 3) Clinical Microbiology Procedures Handbook 3 rd Edition; Issenburg Transfusion Medicine 1) Circular of Information, Canadian Blood Services (most recent version) 2) Canadian Standards Association Blood and Blood Component Z902 (most recent version) 3) Canadian Society for Transfusion Medicine (most recent version) 4) Modern Blood Banking and Transfusion Practices 5 th Edition; Harmening, Denise M. 5) Canadian Medical Association Journal Guidelines for Red Blood Cell and Plasma Transfusion for Adults and Children; supplement to CAN MED ASSOC J 1997; 156 (11) 6) American Association of Blood Banks Technical Manual - most recent edition 7) Bloody Easy 3: Blood Transfusions, Blood Alternatives and Transfusion Reactions 3 rd Edition; Ontario Regional Blood Coordinating Network Hematology 1) Color Atlas of Hematology, Hematology and Clinical Microscopy Resource Committee, CAP; Glassy, Eric F. 2) Clinical Hematology: principles, procedures, correlations 2 nd edition; Stiene-Martin, Lotspeich-Steininger, Koepke 3) Hematology: Clinical Principles and Applications 3 rd Edition; Rodak, Fritsma, Doig 4) Clinical Hematology Atlas 3 rd Edition; Carr/Rodak Chemistry 1) Tietz Fundamentals of Clinical Chemistry 6 th Edition, W. B. Saunders Company; Burtis, Ashwood, Bruns Diagnostic Quality Assurance Program College of Physicians &Surgeons of Saskatchewan 7.8" 3.5"3*&<2,=$#,/$+&>?@>&A=,5,"/& (.%$&H& & 2) Clinical Chemistry – Principles, Procedures, Correlations 6 th Edition; Bishop Urinalysis 1) Graff’s Textbook of Urinalysis and Body Fluids 2 nd Edition; Mundt, Shanahan Anatomic Pathology 1) Histotechnology: A Self Instructional Text 3 rd Edition; Carson & Hladik 2) Principles of Anatomy & Physiology 13 th Edition; Tortora & Grabowski Safety 1) Transportation of Dangerous Goods Act and Regulations Supplement Canada Gazette, Part II [www.tc.gc.ca/eng/tdg/clear-tofc-211.htm] 2) CSMLS Guidelines – Laboratory Safety, 6 th Edition Competency Evaluation 1) Canadian Society of Medical Laboratory Science PO Box 2830 LCD 1 Hamilton, ON L8N 3N8 website www.csmls.org Certification - Competency Profiles