QA-in-TSC-Part-I

Quality Assurance in Transfusion Science Assoc. Prof. Dr. Preeyanat Vongchan

Outline 1. Objectives of quality in blood bank laboratory 2. Quality assurance (QA): - meaning - responsibility - elements 3. Quality management (QM) 4. Quality assessment 5. Quality auditing 6. Quality systems 7. Quality planning 8. Quality control (QC)

Objectives of quality in blood bank laboratory • To ensure availability of a sufficient supply of blood components and high quality with maximum efficacy and minimum risk to both donors and patients • To ensure maximum efficacy and safety of blood • To determine problems in the whole transfusion chain and solving it

4 Examples of failure in quality in blood bank • Failure to identify the donor/patient correctly • Wrong sample labeling • Mix-up of results among different donor/patient • Failure to detect presence of an abnormality in the donor/patient's sample • Issue of unscreened donor blood due to faulty laboratory procedures

Who are involve in quality in transfusion medicine? 5 1. Clinician 2. Phlebotomist (Nurse or person who collects patient’s samples) 3. Blood bank staff (Medical technologist) 4. Transfusionist (Nurse or person who involves in blood transfusion from donor to patient)

Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Quality assurance (QA) • Definition: 8 Systems that is designed and implemented to ensure that manufacturing is consistently performed in such a way as to yield a product (or service) of consist quality. • Goals: 1. To significantly decrease errors 2. To ensure the credibility of results 3. To implement safe and effective manufacturing process and system control 4. To ensure the continued product safety and quality

QA RESPONSIBILITIES • Compliance with current Good Manufacturing Practices (cGMPs) • Review and approval of all Standard Operating Procedures (SOPs) • Specifications and validation protocols • Development, review and approval of training programs • Investigation of product recalls, errors and complaints • Coordination of internal quality auditing programs

Elements of quality assurance • Record and SOPs • Error management • Personal selection and training • Process improvement • Validation, calibration, prevention • Process control • Maintenance, proficiency testing • Label control • Supplier qualification • Internal auditing

Records and documents 11 • Records provide evidence that process was performed as intended and provide information needed to assess the quality of products and services • Documents describe: - how processes work - how they interact - where they must be controlled - what their requirement are - how to implement them

Record keeping Good record keeping Bad record keeping • Use of permanent blue or black ink 12 • Recording data on appropriate form • Use of pencil or nonpermanent ink • Use of correction fluid or white tape when making a correction • Record data on a piece of scratch paper or sticky note • Recording date and initials of person • Not recording date or initials of person making a making a correction correction • Recording data for someone else • Recording data immediately after • Recording data later after performance of task performance of task • Deleting the original entry when making a correction • Not deleting the original entry when making a correction • Indicating “broken”, “closed” or “not in • Not recording “broken”, “closed” or “not in use” when use” when appropriate appropriate • Not using “dittos” • Use of “dittos (ๆ)”

Elements of quality assurance • Record and SOPs • Error management • Personal selection and training • Process improvement • Validation, calibration, prevention • Process control • Maintenance, proficiency testing • Label control • Supplier qualification • Internal auditing

Standard Operating Procedures (SOPs) 14 Written procedures to help ensure the complete understanding of a process and achieve consistency in performance from on individual to another • Principle or purpose • Specimen requirements • Supplies, reagents and equipment • Quality control • Procedure instructions • Interpretations and reporting • References

Elements of quality assurance • Record and SOPs • Error management • Personal selection and training • Process improvement • Validation, calibration, prevention • Process control • Maintenance, proficiency testing • Label control • Supplier qualification • Internal auditing

PERSONNEL QUALIFICATIONS • Selection criteria • Job description • Training • Competency assessment

Selection criteria • Qualification requirements are determined on basis of job responsibilities • Selection process should consider applicant’s qualifications - Education - Training - Experience - MT Licensure - Certifications - etc.

Job description Describe the tasks for which the employee is responsible and outcome areas of knowledge and skill that need to be acquired during training to perform the job

Training • Trainer trains new employee follows SOPs and associate documents. • After training new employee has knowledge and skill to perform the job without the trainer’s assistance. • Employee renews training in proper time to time.

Competency assessment 20 Evaluation of the employee’s ability and knowledge to perform a procedure or skill..by - Direct observation of performance - Written tests - Review of results and records - Using blind samples

Competency assessment • To determine whether the individual is ready to perform a procedure Fail ® need retraining and reassessment • Employee must not be allowed to perform the procedures until retraining is provided and subsequent competency assessment proves to be satisfactory

Elements of quality assurance • Record and SOPs • Error management • Personal selection and training • Process improvement • Validation, calibration, prevention • Process control • Maintenance, proficiency testing • Label control • Supplier qualification • Internal auditing

Supplier qualification Definition: Established procedures to evaluate the quality of critical products and services received from supplier that meet pre-established criteria • Test reagents: antisera, standard red blood cells, infectious marker testing reagents, etc. • Blood bags, blood products

Elements of quality assurance • Record and SOPs • Error management • Personal selection and training • Process improvement • Validation, calibration, prevention • Process control • Maintenance, proficiency testing • Label control • Supplier qualification • Internal auditing

Error management • Errors should be documented and investigated as opportunities for improvement • Blood bank staffs should be encouraged to report errors without concern for punishment • If a problem is identified, an immediate response follows to correct the problem • If a cause is identified, a proposed plan for prevention should be drafted

Elements of quality assurance • Record and SOPs • Error management • Personal selection and training • Process improvement • Validation, calibration, prevention • Process control • Maintenance, proficiency testing • Label control • Supplier qualification • Internal auditing

3 Quality improvements 1. Personnel improvement 2. Process improvement • Training and skill • Improve technique of collection development • Donor comfort • Seminar and workshops • Donor refreshment • Motivation, leadership, • Internal and external quality award and recognition control • Skill assessment • etc. • etc. 3. Product improvement • Quality of blood bags • Sterile procedure of collection • Storage environment • Proper maintenance of records • Techniques in component separation • etc.

28 Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Quality management (QM) Definition: The 1) organizational structure 2) processes and 3) procedure necessary to ensure that the overall intentions and direction of an organization’s quality program are met and that the quality of the product or service is ensured. Includes 1) strategic planning, 2) allocation of resources and 3) other systematic activities (quality planning, implementation and evaluation)

Systems approach for QM 1. Determine the needs and expectation of customer and other interested parties 2. Establish a quality policy and quality objectives 3. Determine the processes needed to obtain those quality objectives and who is responsible for those processes 4. Ensure adequate resources are available to execute those processes 5. Determine and apply methods to evaluate those processes 6. Design ways to prevent nonconformances and ways to correct nonconformances that are not prevented 7. Establish a process for continual improvement of QM

Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Quality assessment Goal: Is to ensure that the results of the investigations are reliable and comparable • Internal Quality Assessment (IQA) • External Quality Assessment (EQA)

Internal Quality Assessment (IQA) Set of procedures undertaken by the laboratory staff for monitoring of the laboratory work in order to decide whether the results are reliable enough to be released Objectives of IQA • To ensure that the results are reliable and reproducible • To control quality of daily routine work

External Quality Assessment (EQA) The use of known samples but undisclosed values and comparison against other laboratories values of the same sample Objectives of EQA • To detect hidden problems • To receive help and support • To compare the performance with others and improve quality

Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Quality auditing Definition: Systematic investigations to determine whether policies and procedures are being performed and supported properly Internal audit External audit Performs by staffs well trained in Performs by specialists from outside quality audit and follows self-checklist organizations of Thai Red Cross Society • To achieve standard accreditation • To ensure personnel are suitably e.g. ISO (Internal organization for trained to perform the procedures standardization), HA (Hospital they are performing accreditation) • To review that SOPs are correct and complete • To ensure that relevant SOPs are being followed

Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Quality systems Definition: Process A Organized and purposeful structure that consists of Input -> action -> output interrelated and independent elements (components, Process C Process B processes, entities, factors, members, parts, etc.) Input -> action -> Input -> action -> output output Goals: To ensure the maintaining of the activity and existence of the system.

Quality system of whole blood collection Input Validation of process to Quality of output ensure the consistent of determined by QC of process input and process - Trained phlebotomist Output - Approved collection set - Approved arm-scrub solution Unit of whole blood - SOP of phlebotomy

Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Quality planning Definition: Systematic process that translates quality policy into measurable objectives and requirements, and lays down sequence of steps for realizing them within a specified time frame Goals: To ensure the success of QMS

Concepts in quality • Quality assurance • Quality management • Quality assessment • Quality auditing • Quality systems • Quality planning • Quality control (QC)

Quality control (QC) Definition: Operational techniques and activities used to monitor and eliminate causes of unsatisfactory performance at any stage of a process and provide feedback to operational staff about the state of a process that is in progress Goals: • Everything is acceptable ® continue process • Something is found to be out of control ® stop process until a problem has been resolved

Quality control requirements in blood bank laboratory 1. Reagents 2. Instrument 3. Blood components to be continued in Part II

Good manufacturing practices (GMPs) • Are requirements established by Food and Drug Administration (FDA) • These regulations itemize \"what\" needs to be done without necessarily specifying \"how\"

Elements of GMPs • Write and follow SOPs • Record and document all work performed • Quality personnel by training and education • Design and build proper facilities and equipment • Clean by following a housekeeping schedule • Validate equipment, personnel and processes • Perform preventive maintenance on facilities and equipment • Control for quality • Audit for compliance with all of the above

47 Data retention (Minimum 5 years for TSC) What to be kept? 1. Pretransfusion results - ABO - Rh blood groups - unexpected alloantibodies, - serologic crossmatch 2. Additional testing to detect unexpected alloantibodies 3. Detection of ABO incompatibility when no clinically significant antibodies are detected

48 Data retention (continue) 4. Sign statements from requesting physician in urgent release of blood before completion of compatibility testing or infectious disease testing 5. Patient consent 6. Final inspection of blood components before issue 7. Verification of patient identification before transfusion 8. Evaluation of suspected transfusion adverse event 9. Patient’s medical record on transfusion

49 Do you have any idea for qualities in transfusion Science ?