Decorating from the inside out – Impact of Accreditation on the quality of our transfusion service
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Transcript of Decorating from the inside out – Impact of Accreditation on the quality of our transfusion service
Decorating from theinside out – Impact of Accreditation on the
quality of our transfusionservice
Ankit MathurRotary Bangalore ttk Blood BankBangalore Medical Services Trust
BMST
• BMST was established in the year 1984 – Rotary Bangalore –TTK blood
bank, Regional Blood Transfusion Center
– Day care Blood Transfusion center
– HLA Laboratory – Community Services
Department • BMST Tissue Bank: Bones &
amniotic membrane
Journey of Accreditation
• Basic Quality Management system was in place • NABH accreditation: 2009• NABH Application : 2011• Achieved : 2011• Technical & Management clauses
Management clauses
• Regular training, training documentation• Competency evaluation• Equipment management• Quality indicators & analysis• Internal audit & ORM• Document control & change control• Incidence reporting & evaluation• Feedback from stakeholders
Quality Manual & Policy
• QM & QP was in place• Organogram & ethics code• Awareness among staff was
not there• Repeated training sessions• Display in each department• IN PRACTICE
Training & Competency evaluation
• Regular training sessions• Good attendance• Effectiveness analysis: pre
& post training questions• Regular competency
evaluation: unknown sample for testing by different people
• Skill Matrix
Quality indicators
• QI were not in place• Set for each lab: blood donation, component sep,
TTI & XM-issue lab as well as HLA lab• Analysis of QI: monthly
Quality Indicators of Rotary Bangalore TTK Blood Bank Quality Indicators of blood donation area:
1. No. of less collection units 2. No. of times when the duration of first collection & the time of units received at
component separation lab is more than 4 hours 3. No. of hematoma or phlebotomy related adverse reaction
Quality Indicators of component separation lab
1. No. of units found non conforming in quality control tests Quality Indicators of TTI lab
1. TTI reactivity 2. No. of cases when ELISA batch failed 3. No. of cases when result of external QC sample not satisfactory
Quality Indicators of Red Cell Serology lab
1. Turnaround time of compatibility testing/ no. of cases when it goes beyond 2 hours
2. Total number of transfusion reactions
Quality Indicators of HLA lab
1. No. of cases when wrong report issued 2. Turnaround time of testing/ no. of cases when it goes beyond estimated or
promised time 3. No. of times test failed/ repeated
Quality Indicators of QA Lab
1. Percentage of component not comply the quality standard 2. No. of adverse events/ non conformities reported 3. No. of events of equipment failure reported 4. No. of incidences when QC of reagents are not satisfactory
Discard details
Less collection
Segment open
Break during centrifugation
TTI reactive Expiry Other
RC
PC
FFP
QI: blood components
• Number of units not comply with quality standards• Cryo precipitate• Started analyzing each step & experimenting• Modification in procedure: thawing & centrifugation• Coagulation lab for QC testing• Finally Cryo is meeting quality standard
Internal Audit
• Vertical & horizontal audit• Single unit audit• IA: once in 6 months• Management Review Meeting• Regular Operational Review Meeting (ORM) :
monthly: performance check list• ORM: useful which give overview of whole blood
bank operation
Operations Review Meeting Check List
Month:
Dept/Section Details
Total BDC
Total blood collections in the
month
Adverse donor reaction &
follow up, specially
phlebotomy problems
Feedback from BDC organizer
& donors
Venue of BDC if required to
be discussed
Communication with Head,
Donor recruitment if required
Total no of less collection
Component prepared
Bag broken
No. of TTI reactive
Total units issued, all
components
QC of all blood component
QC of reagents, Antisera, TTI
& Virotrol
Discussion on Daily QC
sheets
Temperature records of the
last month
Equipment problems,
calibration & any other matter
Training & evaluation of any
new staff, if required
Document control & Change control
• Document control log & its maintenance • Recommendation of change• Reason of change in doc/ procedure/ equipment
or other• Discussed in ORM• Documentation of change control & approval from
QM • Document control log
Doc. No: Document
Version
Total co
Soft cc
hold Hard cc HolderEffective date
I. Management _ _ _ _ _I.A. QMS Manuals _ _ _ _ _I.A.1. Quality Manual _ _ _ _ _I.A.1.a. QM Contents 3 2 MD QM 1.1.12I.A.1.b. QM Vision & Mission 3 2 MD QM 1.1.12I.A.1.c. QM Quality Policy 3 2 MD QM 1.1.12I.A.1.d. QM Introduction & Services provided by BMST 3 2 MD QM 1.1.12I.A.1.e. QM Organization and Management 3 2 MD QM 1.1.12I.A.1.f. QM Organogram 3 2 MD QM, HA 7.11.11I.A.1.g. QM Quality Management System Rotary-TTK Blood Bank3 2 MD QM 1.1.12I.A.2. Process Control Manuals _ _ _ _ _I.A.2.a. PC Establishment 3 2 MD QM 1.1.12I.B. Administration Procedures _ _ _ _ _I.B.1. Documentation _ _ _ _ _I.B.1.a. SOP _ _ _ _ _I.B.1.a.1. Document Control 3 2 MD QM 1.1.12I.B.1.a.2. Creation, validation & implementation of SOP, WI & FC 3 4 MD QM, QCO, TMHLA 1.1.12I.B.1.a.3. Ensuring traceability vein-to-vein 3 6 MD QM, Accts Asst, Stores i/c, TS , Receptionist 1.1.12I.B.1.a.4. Maintenance of Records & Registers 3 6 MD QM, HA, TS, Receptionist, TMHLA 1.1.12I.B.1.d. APX _ _ _ _ _I.B.1.d.1. QMS Documents List _ _ _ _ _I.B.1.d.1.i. Doc Numbering system 3 1 MD _ 1.1.12I.B.1.d.1.ii. Documents master list grey format 3 1 MD _ 1.1.12I.B.1.d.1.iii. Blood bank current documents 3 2 MD QM 1.1.12I.B.1.d.2. Document Control Log 3 2 QM QM 1.1.12I.B.1.d.4. QMS documentation Templates _ _ _ _ _I.B.1.d.4.i.a. QMS document Template 3 1 QM _ 1.1.12I.B.1.d.4.i.b. PC document Template 3 1 QM _ 1.1.12I.B.1.d.4.i.c. SOP Template 3 1 QM _ 1.1.12I.B.1.d.4.i.d. WI Template 3 1 QM _ 1.1.12I.B.1.d.4.i.e. FC Template 3 1 QM _ 1.1.12I.B.1.d.4.i.f. Appendix Template 3 1 QM _ 1.1.12I.B.2. Establishment _ _ _ _ _I.B.2.a. SOP _ _ _ _ _I.B.2.a.1. Vendor Selection 3 3 MD QM, HA 1.1.12I.B.2.a.2. Generator Use & maintenance 3 4 MD QM, HA, 1.1.12I.B.2.b. WI _ _ _ _ _I.B.2.b.1. Finance & accounts 3 3 MD QM, HA, 1.1.12I.B.2.b.2. Fire control 3 8 MD QM, HA (6) 1.1.12I.B.3. Equipment _ _ _ _ _I.B.3.a. SOP _ _ _ _ _
I.B.1.d.2.Document Control Log (Rotary Bangalore-TTK Blood Bank, BMST)
Change control document
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Feed back from stakeholders• Suggestion Box • Blood donors & BDC
organizer• Patient’s relatives• Blood storage center’s in
charge• Physicians & surgeons/ other
hospitals• All feedbacks are discussed
in ORM & action taken
Stakeholder Feedback
1. Rotary Bangalore-TTK Blood bank has been in blood banking service since 1984. It is today one of the largest in Karnataka.
2. It has been our continuous and constant endeavor to upgrade ourselves in terms of quality. With a view to evaluate ourselves, we need a feedback from our stake holders - donors, patients, hospitals, donor organizations and so on.
3. We would be obliged if you could please complete the feedback form given below and return it to us. Please rate our services, as Excellent- E / Very good-Vg / Good-G / Average-A/ Poor-P
4. You may also give suggestions / views which will help us to improve our quality.
Feed-back from blood donors
E Vg G A P
1 Punctuality
2 layout of the blood donation camp
3 Reception
4 Infomation given
5 Blood donation experience
6 Attitude of the Staff
7 Willingness to help / answer questions
8 cleanliness / tidiness at the camp
9 Refreshment
10 Suggestions if any:
Complaints
Error reporting & CAPA• Incidence reporting & evaluation• Incidence form available at each lab• Staff is trained for reporting• Incidences are analyzed by TM & QM• Classified as adverse event, event with no harm
& near miss event• Corrective & preventive action
Incidence reporting system: study• Classified: Identification & classification of events in
transfusion medicine, HS Kaplan; Transfusion vol 38, 1998
Adverse event
Event no harm
Near Miss Total incidences
2010Before Accreditation
0 41 19 60
2011After Accreditation
0 20 47 67
Analysis of Near Misses• Understanding about incidence reporting
improved• More NM: more opportunities of evaluate the
system
Conclusion• Accreditation didn’t solve all the problems• It guided us correct way how to solve
Quality is Infinity Accreditation not the end goal Maintaining QMS is always a challenge
Thank you