Transfusion Medicine Checklists and Challenges Ljiljana Petkovic MTASCPSBB

Transfusion Medicine: Checklists and Challenges Ljiljana Petkovic, MT(ASCP)SBB Checklist Technical Content Analyst March, 2016

Transfusion Medicine: Checklists and Challenges • Today’s presentation will review: – Common checklist deficiencies • Lab General • All Common • Transfusion Medicine – Checklist Challenges • Interpretation of requirements • New requirements © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 20375 Document Control System (Revised in 2015) – Policies and procedures are current – Personnel are knowledgeable – including defined process for introduction of new or revised documents (sign-off sheets, electronic, meeting minutes) – Signed by Laboratory Director before implementation – Procedures reviewed per laboratory policy by director or designee (at least biennially) – Discontinued policies/procedures removed © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 20375 Document Control – Management of document control system applies to labs that are subject to CAP accreditation – More examples of documents listed to include: safety, specimen collection, personnel, and information systems – Card files and summary charts added to list of policies and procedures that must be current. – Records for approval, review and discontinuance are available © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 54400 Personnel Records – Personnel files are maintained and current for all testing personnel – Copy of academic, diploma or transcript of highest degree on file – License acceptable (applicable only for laboratory personnel) if required by state – Credential verification allowed in lieu of diploma providing laboratory can obtain copies within seven days of request and process has been validated (New for 2015) © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 54400 - Personnel Records Required: – Summary of training and experience – Certification, if required by state or employer – Job Descriptions – Records of continuing education – Work-related incident and/or accident records – Dates of employment © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 55500 Competency Assessment - Each non-waived test system – to include all 6 required elements - Waived test systems – elements can be selected - Semiannually during first year of duties for new employees (not required for waived testing) - Annually thereafter - Performed by Technical Supervisor or qualified designee (in writing) © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 55500 - Test Systems – Process that includes pre-analytic, and postanalytic steps to produce a test result or set of results – May be manual, automated or single use – Tests performed on same instrument or device may be defined as a single test system – Tests with unique aspects, problems or procedures within the same testing platform (eg. Eluates) must be assessed as separate test system to ensure staff perform aspects correctly © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 55500 - Who Can Assess Competency? – High Complexity testing- Section director or general supervisor • Individual with minimum of associate’s degree in Medical Laboratory Technology with 2 years of training and/or experience in high-complexity • Doctoral/M. S/B. S degree in clinical lab science or chemical, physical or biological science and 1 year training and experience in high-complexity • Must be delegated in writing by the section director © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 55500 - Who Can Assess Competency (cont’d) – Moderate Complex testing- Technical Consultant individual with a B. S. degree in clinical laboratory science or chemical, physical or biological science and 2 years experience in non-waived testing in designated specialty • Doctoral/M. S degree in clinical laboratory science or chemical, physical or biological science and 1 year training and/or experience in non-waived testing in designated specialty. Visit FDA website to determine testing complexity level © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Laboratory General Checklist • GEN. 55525 Performance Assessment of Supervisors/Consultants – Laboratory Director must delegate responsibilities in writing – Perform and document the performance assessment – If the individual is performing non-waived testing must document competency assessments including the six elements (GEN. 55500) – If state regulations are more strict, follow stricter rules © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – All Common Checklist • COM. 01400 PT Attestation Page (Revised in 2015) – Written signature of Lab Director or designee (electronically submitted signature not acceptable) – Designee must be in writing: – For high complexity testing, may be delegated to individual meeting qualifications of technical supervisor or section director – For moderate complexity testing, may be delegated to individual meeting qualifications of technical consultant © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies- All Common Checklist • COM. 01700 PT Evaluation – Prompt evaluation – All unacceptable results – Includes follow-up/corrective action – Records kept for five years for Transfusion Medicine © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies- All Common Checklist • COM. 04200 Instrument/Equipment Record Review – All instruments/ equipment maintenance and function checks – Reviewed monthly • COM. 04250 Comparability of Instrument/Method – Non-waived instruments/methods; eg, Gel vs. tube method, multiple instruments, etc. – Twice/year – Acceptability criteria defined – Documented review © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – All Common Checklist • COM. 10000 Procedure Manual – Cited when policy does not match practice – Use of manufacturers’ inserts not acceptable in place of procedure manual. – Extra copies of procedures at workstations subject to document control – Complete manual (electronic or paper) must be available in work area – Current and complete (expired removed) © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – All Common Checklist • COM. 10100 There are records of review of all technical policies and procedures by the current laboratory director or designee at least every two years – Laboratory Director or designee (in writing) – New/significantly changed policies and procedures cannot be delegated – Per laboratory policy (at least biennially) – At individual procedure level OR multiple signatures on a list of procedures – Electronic OR written signature acceptable © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – All Common Checklist • COM. 30300 Reagent Labeling – revised expiration date must be recorded on container or log • COM. 30350 Reagent Storage – Per manufacturer requirements – Temperatures recorded daily • COM. 30400 Reagent Expiration Date – used within expiration date © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – All Common Checklist • COM. 30450 New Lot/Shipment – confirmation of acceptability – To confirm that use of new reagent lots and shipments do not affect patient results (i. e. improper storage) – Daily quality control of ABO, Rh and Antibody screen satisfies intent of checklist item – Fetal detection screen kits must be checked when new lots arrive – Does not apply to antibody panels © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – All Common Checklist • COM. 40000 Method Validation/Verification Approval Summary statement signed by laboratory director or designee who meets CAP director qualifications – Written assessment of validation/verification study – Problems discovered, corrective action and resolution is documented and included in summary – Approval of validation plan signed prior to use in patient testing © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Transfusion Medicine Checklist • TRM. 30000 Monthly QC Review – QC records – Temperature records – 7 days/week; 52 weeks/year – Alarm checks • TRM. 31250 Reagent Expiration Date (Revised in 2015) – Reagents used within expiration date – Expired reagents may be used if rare; expectation is for lab to have in-date reagents for routine antibody panel testing © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Transfusion Medicine Checklist • TRM. 31400 Antisera/Reagent Red Cell QC – Records of acceptability performed each day of use – Includes check against known positive and negative cells or manufacturer’s directions for quality control followed • TRM. 41025 Transfusionist Training – Personnel who transfuse blood are trained in observation of transfusions of recipients and in recognition of transfusion reactions – Training done initially and annually © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Transfusion Medicine Checklist • TRM. 42470 Acceptance Back Into Inventory (Revised for 2015) – Written procedure validated by the laboratory including validation of “ 30 minute” rule – Records show appropriate temperatures maintained © 2016 College of American Pathologists. All rights reserved.

Common Deficiencies – Transfusion Medicine Checklist • TRM. 42750 Storage Unit Alarms – Quarterly alarm testing – Alarm checks to include both high and low tests • TRM. 42850 Alarm Sensors To Trigger Action Needed – Set to alarm prior to falling out of range – Corrective action documented – Review documented © 2016 College of American Pathologists. All rights reserved.

Interpretation “challenges” • GEN. 54400/54750 Personnel Records – Personnel license alone acceptable only if required by your state – Copy of diploma or transcript required if state licensure not applicable • Must include course of study, eg, Bachelor of Science in Medical Technology, Biology, etc. – Non-US degrees require foreign equivalency evaluation; eg, NACES, AICE and others – Certification – copy needed only if required by state or employer; eg, ASCP © 2016 College of American Pathologists. All rights reserved.

Interpretation “challenges” • COM. 30450 New Reagent Lot Verification – Applicable to all test kits – For ABO/Rh/Antibody screen, daily QC can meet this requirement – Requires acceptability criteria, records and review • COM. 40250 Manufacturer Instructions – Any change to instructions requires validation – Change in waived test instructions makes test high complexity (and changes personnel requirements) • TRM. 31900 Serologic Centrifuge Checks – RPM and mechanical timer checks required each 6 months © 2016 College of American Pathologists. All rights reserved.

Interpretation “challenges” • TRM. 41525/ 41550/ 41600 Perioperative/ Intraoperative Blood Programs (Revised) – Defined responsibility of Laboratory Director and laboratory in perioperative and intraoperative programs – Documented Laboratory Director involvement in policies and procedures • TRM. 30950 CBER Notification (Revised) – FDA biological product deviation reporting requirements (website: www. fda. gov/cber) – Includes testing, component prep, labeling, storage, and distribution of units © 2016 College of American Pathologists. All rights reserved.

Checklist requirement update New/Revised requirements – 2015 • TRM. 30895 Adequate Blood/Tissue Supply (Revised) - Requires written agreement OR - Letter of understanding between transfusion service and blood supplier • TRM. 30575 Misidentification Risk (Revised) – Now requires facilities to have a system to reduce risk of mistransfusion (rather than a plan to reduce risk) © 2016 College of American Pathologists. All rights reserved.

Checklist requirement update • TRM. 31250 Reagent Expiration Date (Revised) – Lab is expected to use in-date reagents for routine antibody panel testing • TRM. 32232 Pipette Accuracy (Revised) – Added note that minimally, checks to be performed per manufacturer’s instructions and defined • TRM. 40700 Selection of Blood Components (Revised) – Formerly titled Whole Blood/Red Cells/Plasma – Allows provision for transfusion of ABO incompatible plasma © 2016 College of American Pathologists. All rights reserved.

Checklist requirement update • TRM. 41000 Blood Administration Procedure (Revised) – Formerly entitled Transfusion Protocol – Requires written procedure • TRM. 41025 Transfusionist Training (Revised) – Clarification of annual training to include recognition and reporting of adverse transfusion events • TRM. 42650 Transfusion Reaction Recognition (Revised) – Written procedures for clinical actions taken – Deleted “Education” from subject header © 2016 College of American Pathologists. All rights reserved.

Checklist requirement update • TRM. 42110 TRALI (Revised) – Checklist requirement now a Phase II – Laboratory is requirement to have written policies and procedures to recognize, investigate and reduce risk – Sole written record of communication from blood supplier no longer accepted to meet the intent of the requirement © 2016 College of American Pathologists. All rights reserved.

Checklist requirement update • TRM. 45260 Instrument QC (Revised) – Requires that facility follows manufacturers instructions for quality control prior to use in donor screening • TRM. 40215 ABO Typing on Solid Organ Donors (New) – Written policy for ABO typing – A 1 subgroup not to be performed in patients transfused within last three months © 2016 College of American Pathologists. All rights reserved.

Resources • Email : accred@cap. org • Phone: Technical Staff in Laboratory Accreditation: 1 -800 -323 -4040, option 1 • www. accessdata. fda. gov/scripts/cdrh/cfdocs/cf. CLIA/Search. cfm • Lilly Petkovic: lpetkov@cap. org 1 -800 -323 -4040, ext. 7387 THANK YOU! © 2016 College of American Pathologists. All rights reserved.