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The Detailed Hospital Blood Bank Process Flow and ISO 15189

D. Keane May 2005. 2. The Detailed Hospital Blood Bank Process Flow and ISO 15189. DefinitionsRequest to DeliveryIncoming Inspection

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The Detailed Hospital Blood Bank Process Flow and ISO 15189

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    1. D. Keane May 2005 1 Refer to Sequence 6 Acetate No. 10. The Detailed Hospital Blood Bank Process Flow and ISO 15189

    2. D. Keane May 2005 2 The Detailed Hospital Blood Bank Process Flow and ISO 15189 Definitions Request to Delivery Incoming Inspection – Storage Testing Release and Issue to the Ward Post Issue and Transfusion Process

    3. D. Keane May 2005 3 Availability of Medical/ Scientific Advice from Hospital Blood Bank Issues for Expert Group Summary of Clauses Specific to Blood Transfusion The Detailed Hospital Blood Bank Process Flow and ISO 15189

    4. D. Keane May 2005 4 ISO 15189 and Blood Components Critical Consumable Material (4.6.1) Primary Sample (3.11) Equipment (5.3.12, 5.3.14)

    5. D. Keane May 2005 5 3.10 - Pre Examination Procedure Preanalytical phase Steps starting, in chronological order, from the clinician’s request and including the examination requisition, preparation of the patient, collection of the primary sample, and transportation to and within the laboratory, and ending when the analytical examination procedure begins. Definitions are Important

    6. D. Keane May 2005 6 3.11 - Primary Sample Specimen Set of one or more parts initially taken from a system Definitions are Important cont’d

    7. D. Keane May 2005 7 3.14 - Sample One or more parts taken from a system and intended to provide information on the system, often to serve as a basis for decision on the system or its production. Definitions are Important cont’d

    8. D. Keane May 2005 8 Request to Delivery Request for Blood from IBTS Stock Blood Special Preparations Specific Antigen Profile Frozen Blood Components Crossmatch Blood – Distribution/ Storage/ Testing

    9. D. Keane May 2005 9 Request to Delivery Request for Blood from IBTS cont’d A record (4.13) of the request should be maintained by Hospital Blood Bank. Volume/ Quantity/ Type Date/ Time Ordered Date/ Time Required Confirmation of Order Accepted or Amended (4.4.5)

    10. D. Keane May 2005 10 Request to Delivery Request for Blood from IBTS cont’d This is the contract the IBTS have with the Hospital Blood Banks and the product requested is a critical item 4.6.1, 4.6.2, 4.6.3, 4.6.4. Note: Some Hospital Blood Banks order/ test on behalf of satellite Blood Banks. The permanent site is referred (4.1.3, 5.3.1). The minimum turnaround time (4.6.1) from request to receipt of blood should be understood by Hospital Blood Banks dictated at the time of the request and should be clearly understood by both parties.

    11. D. Keane May 2005 11 Request to Delivery Transport and Receipt of Blood Blood transport systems (equipment) 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.43.8, 5.3.9, 5.3.10 (re-qualification), 5.3.12, 5.3.14 (tamper proof) Ownership and validation requirements for Blood Transport Systems require clarification (4.6.1, 4.6.2, 4.6.3 Critical Supplies)

    12. D. Keane May 2005 12 Request to Delivery Transport and Receipt of Blood cont’d The following quality record 4.13 should be maintained by the Hospital Blood Banks. Date/ time left IBTS or Hospital Blood Bank for satellite Date/ time blood received at Hospital Blood Bank or satellite

    13. D. Keane May 2005 13 Incoming Inspection - Storage Transport and Receipt of Blood cont’d The Hospital Blood Bank/ IBTS should monitor the transportation of blood components for:- Turnaround time 5.4.6 (a) Within a temperature range 5.4.6 (b) In a safe manner 5.4.6 (c) Note: Blood from the moment of receipt should be treated as a primary specimen (3.11)

    14. D. Keane May 2005 14 Incoming Inspection - Storage Acceptance of Blood Components on Receipt Treat blood as a primary specimen for labelling, refer to 5.4.3 (c5) “Primary samples shall be traceable normally by request form to an identified individual. Primary samples lacking proper identification shall not be accepted or processed by the Laboratory” (5.4.5) Treat delivery docket as the form 5.4.1

    15. D. Keane May 2005 15 Incoming Inspection - Storage Acceptance of Blood Components on Receipt cont’d Record date/ time of receipt at Hospital Blood Bank (5.4.7) The identity of the receiving officer should be recorded (5.4.7)

    16. D. Keane May 2005 16 Incoming Inspection - Storage Acceptance of Blood Components on Receipt cont’d On receipt accept/ reject the critical consumable (Blood Components) by inspection (4.6.2, 5.4.8) If Blood Components are rejected on inspection, document as a non-conformance (4.9.1, 4.9.2, 4.9.3) The inspection may be a documentation review and/ or a combination of a physical inspection, data review and documentation review (5.4.8)

    17. D. Keane May 2005 17 Incoming Inspection - Storage Acceptance of Blood Components on Receipt cont’d On acceptance the Blood Component (specimen) is received or logged to the Laboratory Information Management System (L.I.M.S.) (5.4.11, 5.4.7, 5.1.7). The time of this transaction should be recorded.

    18. D. Keane May 2005 18 Incoming Inspection - Storage Storage of Blood in the Hospital Blood Bank Using a validated fridge (5.3.2) (map and probe calibration) Ensure a system of continuous temperature monitoring (5.2.5) Ensure blood fridge is secure from uncontrolled access or tampering (5.2.7, 5.3.14) “Storage of primary sample (blood) shall be in accordance with approved policy” (5.7.2)

    19. D. Keane May 2005 19 Incoming Inspection - Storage Storage of Blood in the Hospital Blood Bank cont’d There should be clear segregation/ line clearance with regard to storage of blood Autologous Blood Collection Voluntary Donor Blood Collection Therapeutic Blood Collection Returned from ward for disposal (5.2.6, 5.2.9, 5.2.10)

    20. D. Keane May 2005 20 Testing Request for Blood Components from Hospital Wards Pre-Examination Blood specimens are received from the patient along with a form (prescription) (5.4) The Group/ Crossmatch test is requested to access compatibility of patient for transfusion with a specified number of donor units (5.4)

    21. D. Keane May 2005 21 Testing Request for Blood Components from Hospital Wards cont’d The blood specimens are:- Ordered by Medical staff (5.4.1(b)) Collected by Nursing staff (5.4.1(f)) Received by the Hospital Laboratory (5.4.7) Registered by the Hospital Laboratory (5.4.7) Tested by the Hospital Laboratory (5.5) Traceability should be recorded for these transactions (4.13.3, 5.4.3 (c8), 5.4.11)

    22. D. Keane May 2005 22 Testing Request for Blood Components from Hospital Wards cont’d Pre-examination procedures include:- Documenting availability of tests including turnaround time in a Primary Sample Collection Manual (5.4.3) Proper labelling of specimens (5.4.5) Requirement for a formal test request form or referral letter (5.4.1)

    23. D. Keane May 2005 23 Testing Request for Blood Components from Hospital Wards cont’d Requirement for accept/ reject criteria for specimens (5.4.8) How to deal with requests for additional units (4.4.5) A process for (planned deviation) accepting specimens that do not meet pre-examination requirements (i.e. uncertainty in patient ID) (5.4.5)

    24. D. Keane May 2005 24 Testing Tests are Ordered (Registered) (5.4.7) Group/ Screen Group/ Crossmatch Antibody Identification Patient Genotype Blood Unit/ Patient Antigen Grouping Transfusion Reaction Investigation Serological Investigation of Amniotic Fluid Direct Coombs Test Including Mono Specific Tests Elutions

    25. D. Keane May 2005 25 Testing Tests are Ordered (Registered) cont’d Note: Registration of specimens on the system implies acceptance of the contract (4.4)

    26. D. Keane May 2005 26 Testing Testing in the Hospital Blood Bank Key Requirements Test Method Validation (test method file) (5.5.1, 5.5.2) Equipment Validation (equipment file) (5.3) Internal Quality Control (5.6.1) External Quality Control (5.6.4) Proficiency of Personnel (applies to test methods only) (5.1.11)

    27. D. Keane May 2005 27 Testing Test Method Validation Requirements Verify method by validating that its performance characteristics meet stated requirements (5.5.4) For Transfusion Science, accuracy is the only validatable performance characteristic Requires retrospective validation based on:- Performance in EQA programmes (5.6.4) Inter Laboratory comparisons (5.6.5)

    28. D. Keane May 2005 28 Testing Test Method Validation Requirements cont’d For new test method requirements for comparative methodology testing with N ? 20 Requirement to verify on an ongoing basis that the method meets its performance specification (5.5.2) Documented procedures to define the testing protocol (5.5.3) including sampling of the blood unit using the segment line (5.4.12)

    29. D. Keane May 2005 29 Testing Test Method Validation Requirements cont’d A test method file could contain (5.5.2, 5.5.3, 5.5.7):- Method Change Control Log Plan for Test Method Validation Validation Data and Approvals L.I.S. Data to Support Validation Test Report to Support L.I.S. Parameterisation Method Summary Sheet Report

    30. D. Keane May 2005 30 Testing Test Method Validation Requirements cont’d On-going Verification Data Manufacturer’s Inserts/ Methods Communication to Wards/ Clinicians (5.5.7) One test method file should suffice for Transfusion Serology

    31. D. Keane May 2005 31 Testing Equipment Requirements Master List (Asset Register) (5.3.3) Validation/ Calibration/ Service Contract/ P.M. as required (5.3.2) Training Performed (5.3.5) Procedures (5.3.6) Labelling Defective Equipment (5.3.7) Maintenance/ Safety for Internal/ External Staff (5.3.8) For equipment outside its permanent control (4.1.3, 5.3.1)

    32. D. Keane May 2005 32 Testing Equipment cont’d Calibration Status Labels (5.3.9) Movement of Equipment and Re- Calibration (5.3.10) Validation of Automated/ Computerised Equipment Including Software (5.3.11 & Annex B) Handling/ Transport/ Storage of Equipment (5.3.12) Access to Equipment (security) (5.3.14)

    33. D. Keane May 2005 33 Testing Equipment cont’d Equipment Validation Documentation Equipment File should contain (5.3.4):- Purchasing Documentation Including CE Certification User Requirement Specification Validation (plan, results/ executive summary) Service Contract/ schedules/ records Equipment Manual

    34. D. Keane May 2005 34 Testing Equipment cont’d Cleaning Records Decommissioning Documentation

    35. D. Keane May 2005 35 Testing Validation Notes Validation type depends on whether the equipment was a testing capability or not The line where equipment validation stops and method validation begins must be clearly identified For the validation of equipment, keep similar pieces of equipment in one Method File

    36. D. Keane May 2005 36 Testing Equipment to Consider Fridges/ Freezers/ Incubators/ Waterbaths Pipettes/ Thermometers/ Scales/ Centrifuges/ Immufuges Automated Group/ Crossmatch/ Screening Equipment Manual Group/ Crossmatch Equipment Automated Temperature Monitoring Systems Heat Sealers

    37. D. Keane May 2005 37 Testing Competency of Staff Scientific/ Medical only (5.1.11) Achieved by:- External Quality Assessment Schemes (EQA) Specimens of known measurement EQA programme titled “Blood Transfusion Laboratory Practice Scheme” Providing Body “UK NEQAS” Frequency 10 Distributions per year

    38. D. Keane May 2005 38 Testing Competency of Staff cont’d Each person must be assessed annually (INAB guideline) Training file maintained for each person

    39. D. Keane May 2005 39 Testing Internal Quality Control (IQC) Valid IQC methods must be in place for each test method or process (5.6.1) QC material must be traceable to certified material (5.6.3) The term “QC failure” must be defined New QC material must be tested in advance of use

    40. D. Keane May 2005 40 Testing Internal Quality Control (IQC) cont’d IQC performed same time as assay Document as non-conformance in the event of failure (4.9.1, 4.9.3)

    41. D. Keane May 2005 41 Testing External Quality Assessment (EQA) External Quality Assessment (5.6.4) A valid test method must be subject to EQA or inter laboratory comparison Treat EQA specimens as “real” specimens Review performance at regular intervals Post results in the laboratory Document failure as a non-conformance and perform appropriate look back (4.9.1, 4.9.2, 4.9.3)

    42. D. Keane May 2005 42 Testing Testing Conclusion Must prove competent staff are using a validated test method, which is supported by well maintained, validated and calibrated equipment in a suitable environment. The proof of this is on-going satisfactory performance in the EQA scheme.

    43. D. Keane May 2005 43 Release and Issue to the Ward Results/ Reporting N.B. Results of serological tests determine the availability of blood for transfusion. Results controlling by 5.8 (all sections are relevant) Require procedure controlling the release and reporting of results:- Electronic/ Manual Authorisation (who) Report type (hardcopy/ softcopy) and master document

    44. D. Keane May 2005 44 Release and Issue to the Ward Results/ Reporting cont’d Transaction log in place to control electronic release Notification of healthcare worker when action limit is reached (i.e. urgent crossmatch) Who can receive results? Results released within an agreed turnaround time Contingency in the event of computer failure (4.9, 5.3.1) Interim reports

    45. D. Keane May 2005 45 Release and Issue to the Ward Results/ Reporting cont’d Amended reports Verbal reports Faxed reports Re-printed reports (copies) Archiving retention policy (4.3.1)

    46. D. Keane May 2005 46 Release and Issue to the Ward The Crossmatch Labelling Process after Testing in the Hospital Blood Bank Is linked directly by the results process for example:- Pending tests (no label) Anomalous/ conflicting results (no label) Valid results (label)

    47. D. Keane May 2005 47 Release and Issue to the Ward The Crossmatch Labelling Process after Testing in the Hospital Blood Bank cont’d Crossmatch labelling blood Must meet requirements defined in document titled “Guidelines for the Administration of Blood/ Blood Components”

    48. D. Keane May 2005 48 Release and Issue to the Ward The Crossmatch Labelling Process after Testing in the Hospital Blood Bank cont’d Three documents are issued after successful testing:- Test report Crossmatch labels by number of units of blood crossmatched Spare label for the patient file N.B. The label is an abbreviated test report (traceability)

    49. D. Keane May 2005 49 Release and Issue to the Ward The Crossmatch Labelling Process after Testing in the Hospital Blood Bank cont’d A final labelling check should be performed and recorded (4.3.2 (a)) The master copy report and crossmatch label are retained permanently in the patient file (4.3.1, 4.13.3)

    50. D. Keane May 2005 50 Release and Issue to the Ward Issue of Blood to the Ward Collection of blood by the ward (Medical/ Nursing/ Care Assistants). This step signifies the end of the Hospital Blood Bank responsibility (4.4.1) Access to the fridge should be controlled (electronic software system) (5.2.7, 5.3.14) The wards inspect the primary specimen (blood), check labels etc. and maintain traceability by recording in the Hospital Blood Bank Transfusion Book or electronically (4.13)

    51. D. Keane May 2005 51 Release and Issue to the Ward Issue of Blood to the Ward cont’d Date Patient Name Hospital Number Product Description

    52. D. Keane May 2005 52 Release and Issue to the Ward This is as far as ISO 15189 goes as it applies to traceability.

    53. D. Keane May 2005 53 Post Issue and Transfusion Process Return of Blood from Wards for Disposal or Re-Use Blood should be disposed of in a safe manner and recorded 5.2.10 states “Storage and Disposal of Dangerous Materials Shall be Those Specified by Relevant Regulations”. Records Required (4.13) Re-use if < 30 mins out of fridge. Records required (4.13) 4.4.5 states “If a contract needs to be amended after work has commenced the same contract review process shall be repeated and any amendments communicated to all parties”.

    54. D. Keane May 2005 54 Post Issue and Transfusion Process Archiving/ Disposal of Crossmatch Specimens Post Define minimum archiving period must be defined (5.7.2) Disposal of specimens should be safe – regulations (5.7.3) Note: Review the Royal College of Pathologists document titled “Retention and Storage of Pathological Records and Archives”

    55. D. Keane May 2005 55 Post Issue and Transfusion Process Surveillance/ Haemovigilance/ Hospital Transfusion Committee 4.12.4 states “Laboratory Management shall implement quality indicators for systemically monitoring and evaluating the Laboratory contribution to patient care” Laboratory Management forms part of the Transfusion Hospital Committee who should review at regular intervals:- Inventory Management Hospital Transfusion Policy Haemovigilance Reports

    56. D. Keane May 2005 56 Post Issue and Transfusion Process Surveillance/ Haemovigilance/ Hospital Transfusion Committee cont’d The above review process should feed into Quality Management Review process (4.15.2 (1), 4.15.3) Note: The implementation of a bar-coded patient ID system for specimen labelling, patient arm band and Crossmatch labels is recommended as a risk reduction measure.

    57. D. Keane May 2005 57 Availability of Medical/ Scientific Advice from Hospital Blood Bank Availability of Method/ Scientific Advice from Hospital Blood Bank (4.7) Pre Transfusion During Transfusion Post Transfusion Hospital staff must know who to contact, refer to Primary Sample Collection Manual (5.4.3)

    58. D. Keane May 2005 58 Availability of Medical/ Scientific Advice Best Practice Committee Haemovigilance Officer Hospital Transfusion Committee

    59. D. Keane May 2005 59 Issues for Expert Group Re-routing/ re-transfer of blood? Accept blood components are equivalent to primary samples for the purpose of interpretation? Service agreement between IBTS and Hospital Blood Banks?

    60. D. Keane May 2005 60 Adopting existing technical standard or drafting new Irish ones? 5. Defining minimum acceptance criteria for blood on receipt and transport of blood (acceptable methods)? 6. Ownership and responsibilities for primary transport systems validation including transfer proof? 7. Requirement for temperature mapping? Issues for Expert Group cont’d

    61. D. Keane May 2005 61 Acceptance of IBTS dispatch docket is equivalent to a test request form? 9. Permanent (primary) and secondary sites and accreditation? 10. Minimum criteria for validation of computer systems? 11. Requirement for a formal change control system? Issues for Expert Group cont’d

    62. D. Keane May 2005 62 Requirement for recording date/ time of receipt? 13. Minimum requirements for temperature monitoring:- Calibrated thermometers (type?) Continuous monitoring system 14. Segregation requirements for blood, will one fridge suffice? Issues for Expert Group cont’d

    63. D. Keane May 2005 63 Interpretation of minimum criteria for verification of full traceability? 16. Minimum retention time for storage of archive records and specimen/ samples? Issues for Expert Group cont’d

    64. D. Keane May 2005 64 Summary of Clauses Specific to Blood Transfusion 3.10 – Definition of Pre-Examination Procedures 3.11 – Definition of Primary Sample 3.14 – Definition of Sample 4.1.3, 5.3.1 – Reference to the permanent site and control of equipment outside the permanent site.

    65. D. Keane May 2005 65 Summary of Clauses Specific to Blood Transfusion cont’d 4.2.4 (H) – Accommodation and (L) environment 4.3.1, 4.13.3 – Xmatch test reports and requirement for Xmatch label to be retained permanently in the patient file 4.3.1 – Documents of external origin 4.3.2 (A) – Final labelling check after xmatch results and before releasing to the ward.

    66. D. Keane May 2005 66 Summary of Clauses Specific to Blood Transfusion cont’d 4.4.1 – Review of contracts with blood establishment/ wards/ secondary institutions 4.4.5 – Amendment to contract (additional units) or where blood is returned to fridge for further use when out of fridge < 30 mins. 4.6.1 to 4.6.4 – Control of critical suppliers e.g. IBTS

    67. D. Keane May 2005 67 Summary of Clauses Specific to Blood Transfusion cont’d 4.7 – Advisory services 4.8 – Complaints from users re. Blood Transfusion 4.9.1 to 4.9.3 – Control of non conforming events regarding Blood Transfusion

    68. D. Keane May 2005 68 Summary of Clauses Specific to Blood Transfusion cont’d 4.12.4 – Review quality indicators as it applies to blood transfusion and the laboratories contribution to patient care. Inventory management Adverse events Haemovigilance reports

    69. D. Keane May 2005 69 Summary of Clauses Specific to Blood Transfusion cont’d 4.13 – Quality and technical records including archive requirements 4.15.2, 4.15.3 – Feeding blood transfusion quality indicator data into the management review process. 5.1.11 – Proficiency of scientific staff 5.2.1, 5.2.4, 5.2.5, 5.2.6, 5.2.7, 5.2.9, 5.2.10 – Accommodation and Environmental conditions

    70. D. Keane May 2005 70 Summary of Clauses Specific to Blood Transfusion cont’d 5.3 (all sections) – Laboratory equipment including transport systems for blood components 5.3.2 – Fridge mapping and probe calibration 5.3.1 – Contingency in the event of computer failure 5.3.14 – Transport systems should be tamper proof

    71. D. Keane May 2005 71 Summary of Clauses Specific to Blood Transfusion cont’d 5.4.1 – Request form, blood delivery docket 5.4.2 5.4.4 5.4.3(C) – Labelling of blood components and the primary sample 5.4.5 – “Primary samples lacking proper identification shall not be accepted or processed by the Laboratory”

    72. D. Keane May 2005 72 5.4.6 (A)(B)(C) – Transportation of blood and specimen from IBTS and to wards and or secondary facilities 5.4.7 – Receipt of blood specimens (date and time) 5.4.8 – Acceptance/ rejection of specimens/ blood components Summary of Clauses Specific to Blood Transfusion cont’d

    73. D. Keane May 2005 73 Summary of Clauses Specific to Blood Transfusion cont’d 5.4.11, 5.4.7, 5.17 – Traceability of blood components on the IT systems 5.4.12 – Sampling for testing (segment lines) 5.4.14 – Storage of specimens prior to testing 5.5 – All sections apply to xmatching analysis

    74. D. Keane May 2005 74 Summary of Clauses Specific to Blood Transfusion cont’d 5.6 – All sections apply 5.7.2 – Storage of specimens post testing 5.7.3 – Safe disposal of specimens post storage 5.8 – All paragraphs apply 4.10.1, 4.10.2, 4.11.1, 4.12.2, 4.12.3, 5.5.5 and 5.5.7 – Change Control

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