• NAME : Dr. C.SHIVARAM

• DESIGNATION: Consultant & Head

Transfusion Medicine ,

MANIPAL HOSPITAL BANGALORE

• Honorary Posts:

• Technical committee member and Principal Asessor -NABH

Blood Banks.

• Member –National Haemovigilance Committee and state

Convenor –Karantaka

• Invited Member – Transfusion Resource Group –National

Blood Transfusion Council .

• Honorary Fellow- Society for Regenerative medicine

• Technical Consultant to State Blood transfusion council , NACO,

as resource person for annual training programs.

Transfusion Audit and

Role of Hospital Transfusion Committee

Dr C. Shivaram

Consultant and Head-Transfusion Medicine

Manipal Hospital Bangalore

Transfusion audits

• An audit is a methodical, defined review of practices and policies to ensure safe and appropriate transfusions. (AABB)

• A systematic independent examination and review to determine whether actual activities and results, comply with planned arrangements.(NACO).

• An audit is a process of gathering evidence to e aluate ho ell an organisation’s processes and procedures match a set of audit criteria.

Audits are always carried out against a defined set of criteria

Audit Criteria

• Criteria may be as per legal or

accreditation needs.

• Criteria should be tailored to

the needs of the hospital .

• Key medical staff and clinical

departments should be

involved in their development

process.

• Criteria chosen are initially

Liberal and more stringent

criteria are adopted later.

• Review committee(HTC)

should be flexible and modify

them as needed.

• Criteria may be explicit or

implicit or a combination of

both

Audit Criteria

Explicit

Measurable

Lab Values

No of units

No of donors

Implicit

Subjective

Medical History

Clinical assessment Diagnosis

Involve Individual Judgement

Types of Audit

Horizontal Vertical Examination

Horizontal audit examines

one element in a process

on more than one item.

Ex: Blood donation

( Comprising of

counseling, collection,

storage,labelling etc)

A Vertical

audit examines

multiple elements in a

process, on one item .

Ex : Tracing a unit of

blood from collection

till issue/disposal.

An Examination audit

examines a person

undertaking a test

procedure.

•Comparison with SOP.

•Understanding of the

procedure

Standardizing Transfusion Practices

• Even within the same hospital, transfusion practices vary from one doctor to another for the same procedure/ condition based on the surgeon’s/physicians tolerance to anemia or blood counts, rather than the physiological tolerance of the patient.

• Distribution of blood by the blood centre, both nature and time taken varies from one patient to another even for similar conditions.

• Administration and monitoring of blood is not always uniform in all wards in a hospital .

Transfusion audits and the Hospital

Transfusion committee (HTC)

plays a pivotal role in removing such

anomalies and bringing about

standardization of transfusion

practices within the institution.

Local policies and protocols are

developed from national/

international guidelines.

Need for Hospital Transfusion Committee

• Mark Friedman in a study states that lack of knowledge regarding transfusion medicine among clinicians is possibly the major obstacle in making transfusion practices more consistent.

• HTC- For educating end-users, setting down policies and protocols and promoting safety, efficacy, and efficiency of blood transfusion services.

• Requirement as per National Blood policy. State and union governments need to ensure that HTCs are established.

• Requirement of accreditation : Many accreditation agencies like NABH in India, or JCAHO in the United States insist on a HTC. – An attempt should be made by HTCs to cover all aspects of

transfusion from vein to vein.

Objectives of HTC

SAFE

DONOR

• Laying done/Ratifying policies for safe donor selection Ex : Discouraging directed donations .

• Motivating people to donate blood voluntarily

SAFE

BLOOD

• Review Policies and Protocols for testing/processing blood.

• Ex Review of newer methods of testing like NAT.

• Ex Review Processing technologies like leuko -reduction, irradiation and pathogen reduction.

SAFE TRANS- FUSION

• Set down, rational transfusion guidelines, MSBOS and patient identification procedures.

• Ensuring that right blood goes to the right patient in the right dose based on defined scientific criteria/guidelines.

Scope of HTC

• Scientific and ethical guidelines for the

practice of good transfusion medicine, in

conformance with nationally/ international

accepted criteria modified to suit the local

requirements of the hospital.

• Licensing requirements, administrative issues

and financial matters is not the responsibility

of this committee.

Audit Parameters

BLOOD ORDERS/ REQUESTS

• Units transfused.

• Patients transfused

• Units transfused per patient transfused

• Special components

• Units returned unused.

• Transfusion guidelines.

• MSBOS?

DISTRIBUTION OF BLOOD

• Turnaround time-Definition and calculation

• Emergency requests.

• C:T ratios

• Un-cross matched units.

• Surgical cancellations due to unavailability of blood.

• Significant Group/type switches

• Outdate rate.

• Wastage rates.

Administration and Monitoring

• Blood issue/delivery errors.

• Blood administration policies and procedures

• Transfusion equipments.

• Special transfusion situations.

• Compliance with transfusion guidelines.

• Transfusion reactions.

• Documentation of Transfusions.

• Transfusion-transmitted disease.

• Look-back

www.manipalhospitals.com

•Adverse donor reaction rate

•Donor Deferral rate

•TTI percentage

•Wastage/Discard Rate

•TAT for blood issues

• Component QC failures

• Adverse Transfusion Reaction rate

•Percentage of components

•TTI outliers%-No. of deviations

Quality Indicators

According to NABH BB requirement

Blood Donors 2012-2014

12304 12365

11384

10548 106489797

1756 1717 1587

0

2000

4000

6000

8000

10000

12000

14000

2012 2013 2014

Counseled

Donated

Defered

2012 2013 2014

Deferral % 14.3% 13.9% 13.9%

www.manipalhospitals.com

Adverse donor reaction

ADVERSE DONOR REACTION RATE

2013 2014

144/10468

1.37%

118/9797

1.43%

Introduction of Donor Haemovigilance form for improved reporting

NO SERIOUS ADVERSE REACTION REPORTED

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Percentage of transfusion reactions

Year 2012 2013 2014

No. of

Transfusion

Reactions

42 34 31

No. of

issues

22767 23600 24123

Percentage

of

Transfusion

reaction

0.18% 0.14% 0.13%

1

19

14

9

0 0 0 0

10

14

0

1 1

5

3

15

12

0 0

1 1

2

0

2

4

6

8

10

12

14

16

18

20

2012

2013

2014

www.manipalhospitals.com

TTI outliers %-Deviations beyond 2SD-NONE

CumulativeTTI Rate : Target less than 1%.

2012

2013

2014

4(0.04%) 5(0.04%) 6

HBSAg 86(0.82%) 50(0.47%) 43

HCV 7(0.07%) 4(0.04%) 0

Syphilis 6(0.06%) 2(0.02%) 2

Malaria 0(0%) 0(0%) 0

Cumulative TTI rate

0.97% 0.57% 0.52%

4

86

7 6

0

5

50

4 2

0

6

43

0 2

0 0

10

20

30

40

50

60

70

80

90

100

HIV HBsAg HCV Syphilis Malaria

2012

2013

2014

www.manipalhospitals.com

Discard/Wastage rate

Year 2012 2013 2014

No. of units discarded (Date Expiry, Positive units etc)

2847 1958 1588

Total No of units prepared

25614 25558 25711

% of wastage 11.11% 7.65% 6.17%

Wastage Blood Bank Level

Year 2013 2014

Units returned after issue 52 34

Units discarded after return 5 3

Total no. of units issued 23600 24123

% of wastage 0.02% 0.01%

Wastage Ward Level

2847

1958

1588

0

500

1000

1500

2000

2500

3000

2012 2013 2014

No. of units discarded

No. of units

discarded

www.manipalhospitals.com

Blood usage-Surgical specialties

2816

632

212 135

293 308 229

90 92 194

2197

676

168 238 461 291

178

103 129 238

3184

659

166 244

346 327

188 142 114

387

0

500

1000

1500

2000

2500

3000

3500

CTVS Ortho/Spine General Gastro Neurosurgery OBG Vascular Plastic Urology Onco Surg

2012 2013 2014

10863

(61%)

6814

39% Medical

Surgical

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Blood usage-Medical specialties

1745

2778

1307

232

786

391

1479

3679

1010

281

867 833

1191

4055

1304

247

757

165

0

500

1000

1500

2000

2500

3000

3500

4000

4500

Internal Med Oncology Nephro Cardio Gastro Neuro

2012

2013

2014

10863

(61%)

6814

39% Medical

Surgical

HTC: Constitution • Hospital Transfusion Committee (HTC) should have a fair

amount of representation from all departments across the hospital.

• There need not be a bar on the number of members.

• Desirable to have the heads of the departments or their designees in the HTC.

• Minimum number (Quorum) to conduct the meeting should be defined-including the nature of members.

• Surgeon, Physician, Obstetrician, Intensivist, Oncologist, Pediatrician, Nursing representative/Quality representative besides Transfusion Medicine specialists are desirable in the committee.

• Administrative staff, Human resource personnel purchase , Finance staff may be involved as needed as special invitees.

Terms of Reference of HTC

• To set Policy and protocols to ensure adoption of rational transfusion practices.

• To set down guidelines for Prophylactic and Therapeutic Transfusions (Thresholds levels for transfusion)

• To examine and ratify all Transfusion Policies in the hospital

• To review and ratify a procedure for positive patient identification and blood transfusion

• To design and implement a Hospital Haemovigilance system that is in conformance with the National haemovigilance.

Common Minimum Agenda

• Review quality indicators pertaining to

transfusion services.

• Review of Customer Complaints.

• Hospital Haemovigilance -Review of Adverse

transfusion reaction-

• Results of audits - Audits may be concurrent or

retrospective, horizontal or vertical.

• Ratify change in process or induction of new

processes likely to have a bearing on transfusion.

Additional Responsibilities of HTC

• Policies and protocols for emergency transfusions.

• Review Protocols for Massive Transfusions.

• Review protocols for special transfusion situations like AIHA/DIC etc.

• Review protocols for special needs like IUT/neonatal transfusions.

• Set and review transfusion/testing protocols for special needs like BMT/Organ transplants.

Documentation of HTC Meetings

• Compendium of policies and protocols specific to the institution and current and valid documents cleared by HTC made available across the hospital.

– Meeting Notice with Agenda

– Attendance sheet

– Minutes of the meeting with timelines and responsibility.

– Policy decisions taken/ratified.

– Protocols discussed and accepted.

– Quality indicators/others issues discussed.

Take Home Transfusion Audits and HTC

• Transfusion audit is a systematic review of institution specific transfusion

policies and protocols as laid down by the transfusion service and

approved by the HTC.

• Transfusion audits must cover all aspects from vein to vein and may be

horizontal or vertical; prospective, concurrent or retrospective.

• Audit Criteria may be implicit or explicit or a combination of both.

• Audit criteria must include Blood orders, Blood distribution, Blood

administration and monitoring of transfusions.

• HTC is a legal and accreditation requirement comprising of all end users

of blood , to monitor and ratify new policies and protocols.

• HTC plays a key role in setting down institutional policies to ensure

rational transfusion practices, hospital haemovigilance thereby mitigating

risk of transfusion.

• HTC provides a co-ordinated leadership by a multidisciplinary team of

experts .

THANK YOU!

shivaram@manipalhospitals.com