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

14

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