HOW TO MANAGE QUALITY PROBLEMS AND COMPLAINTS IN TRANSFUSION MEDICINE?

Tomislav Vuk, MD, PhDCroatian Institute of Transfusion Medicine

Zagreb, Croatia

Antalya, 2019

TRANSFUSION MEDICINE

Special place of transfusion medicine in medical science:

• complex algorithms of donor selection and testing• variability of the initial material and final products• specific risks associated with their use• many inter-connected segments• numerous participants• laboratory medicine, clinical medicine, pharmaceutical-like production• patients and blood donors

TRANSFUSION MEDICINE

• great responsibility of transfusion services to provide accessible and safe transfusion therapy

• tremendous progress in terms of quality and safety in transfusion medicine• most of the activities in transfusion chain take place without any problems

• some risks are still present

• the biological origin of blood products - transfusion-transmissible infections

- immune-mediated transfusion reactions

• complexity, numerous participants in transfusion chain- errors

Importance of implementing a QMS in transfusion medicine was early recognized.

HAEMOVIGILANCE

• 1991 - France• unexpected or undesirable effects of transfusion treatment (blood safety concept) • the scope of haemovigilance has evolved • entire transfusion chain („vein to vein”)• HV = risk monitoring system • HV = quality process• full integration of haemovigilance in the quality management system

ROLE AND IMPORTANCE OF QM/HV

• QM and HV: activities continuously intertwined• joint goals of high quality, safe and efficacious transfusion treatment • proper functioning of all activities in the entire process of transfusion medicine• continuous monitoring• CAPA• improvement

PREVENTIVE APPROACH

• preventive approach- preventing things from getting badly- when things go badly - preventing and mitigating damage by a correct and rapidresponse

Preventive strategies:• comprehensive risk management• education• definition of critical control points• permanent quality monitoring and vigilance• audits• identification of opportunities, etc.

MANAGING QUALITY PROBLEMS AND COMPLAINTS –GENERAL PRINCIPLES

• quality – responsibility of all employees

• team work and cooperation

• knowledge and professional competence

• human qualities

• structured protocol

• each decision should be properly documented

DECISION MAKING

• process of choosing among different action options (alternatives)

• intuition vs. reasoning• knowledge, experience, facts, relevant information

• difficulties on making decisions:- complex problems

- situations when we feel uncertainty

- lacking or inadequate data- serious consequences of decisions

COMMUNICATION

• inappropriate communication = misunderstandings and conflicts• written and verbal communication skills• two-way process• ability of active listening• transfer of information and education• effective problem solving• better management of conflict situations• the skill of written communication:

- responding to complaints- making complaints

TEAM WORK

• important tool in achieving common goals• the scope of tasks to cover is steadily increasing and growing ever more complex

“ None of us is as smart as all of us”Japanese proverb

"Coming together is a beginning; keeping together is progress ;working together is success.“

Henry Ford

CAUSES OF QUALITY PROBLEMS

Blood banksquality problems are often manifested on blood products• biological origin of blood products• human errors• poor quality of materials and equipment used in product realization• suboptimal planning and organization of workHospital transfusion unitsproblems are most commonly related to pre-transfusion testing• errors in pre-analytical phase• selection or issue of blood components for transfusionClinical transfusion practice • many activities that are not directly under the jurisdiction of BTS• BTS can affect them through hospital transfusion committees, education of clinical staff, and

so on

NONCONFORMITIES: DONOR SELECTION/BLOOD COLLECTION – CITM 2017

24.94

17.25 16.4611.76

8.485.88 5.43

1.92 1.81 1.361.41 0.452.83

42.2

58.7

70.4

78.9

84.8

90.292.1 93.9 95.3 96.7 97.2 100.0

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

100.00%

BLOOD COLLECTION

• special place and role in the transfusion chain• many critical sites influencing the quality of blood components• skill and experience of the technicians• collection failures - considerable economic loss for blood collecting institutions

- reputation of the blood establishment- donor motivation

BLOOD COLLECTION

Vuk T et al. Blood collection staff education in the prevention of venepuncture failures and donor adverse reactions: from inexperienced to

skilful staff. Blood Transfus 2015;13:338-339.

BLOOD COLLECTION

Vuk T et al. Blood collection staff education in the prevention of venepuncture failures and donor adverse reactions: from inexperienced to

skilful staff. Blood Transfus 2015;13:338-339.

„Overall data suggest that optimal initial education of staff members performing blood collection should take 5-6 months, while taking into account that up to one year is needed to acquire desired skill and experience.”

VENIPUNCTURE FAILURES

0.75 0.800.70

0.850.79

0.74

0.931.03

0.95

0.750.74

0.53

0

0.2

0.4

0.6

0.8

1

1.2

I II III IV V VI VII VIII IX X XI XII

%

months

VENIPUNCTURE FAILURES

UCL

objective

Croatian Institute of Transfusion Medicine – 2017 data

IMPORTANT QUALITY INDICATOR!

Venipuncture failures (CITM) • failed insertion of the needle into the vein• interrupted collection (hematoma, poor/absent flow, donor reaction...)

VENIPUNCTURE FAILURES – CITM 1998-2017

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

1.47

1.28

0.66

0.5

0.670.61

0.89

0.69

0.52

0.64

0.92

0.73 0.7

0.81

0.920.85 0.81 0.8

0.97

0.79

%

Years

POST-DONATION INFORMATION (PDI)

Croatian Institute of Transfusion Medicine (CITM) Zagreb, CroatiaYear: 2017 269 PDI

PDI(269)

EARLY58 (21.6%)

LATE211 (78.4%)

During donation (blood withdrawal) or

immediately after

After donationbut before next

donation/attendance

Tattoo/piercing: 50 (23.7%)Surgical procedures: 48 (22.7%) Travel: 41 (19.4%)Endoscopy: 31 (14.7%)Infections/contact: 8 (3.8%)Other medical conditions: 33 (15.6%)

Subsequentdonation(s)

Infections/contact:27 (46.6%)

PDI

• risk assessment- quality/safety of blood components- safety of blood donors

• cooperation with HBB and clinicians- recall- look-back

• cooperation with fractionators- contracts

• counseling blood donors- further donations

• education- blood donors- staff

NONCONFORMITIES - BC PREPARATION/ STORAGE/ QUALITY ASSESSMENT (CITM 2017)

33.4931.75

11.728.18

3.11 2.07 2.04 1.27 0.85 0.70 0.34 0.34 0.31 0.283.55

65.2

77.0

85.188.3

90.392.4 93.6 94.5 95.2 95.5 95.9 96.2 96.5

100.0

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

100.00

%

OUTDATED BLOOD COMPONENTS

• BC - valuable resource• responsible management• careful planning of blood collection• stock management• low discard rate: savings, better allocation of resources

0

1

2

3

4

5

6

7

8

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

5.1

8.0

5.8

4.3

7.47.9

7.4

4.3

3.7 3.9

2.7

3.7

1.5

3.4

1.9

0.9

3.4

1.71.4

2.27

%

Years

Figure: Outdated PLT concentratesCITM 1998-2017

PRP method “buffy-coat” method

LIPEMIC PLASMA

0

2

4

6

8

10

12

14

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

3.6

5.46

8.49.1

12.712

10

7.9

6.6

8.3

9.2

6.35.5

4.65.3

7.1

5.6

6.5

3.97

%

Year

CITM – lipemic FFP for clinical use 1998 -2017

Corrective actions

donor factors testing problems product loss

MANAGEMENT OF NONCONFORMING QC RESULTS (SPC)

Nonconforming

QC result(s)

Additional

investigation

Accidental

process variation

System

problem

Root cause

analysis

Corrective

action

Initial

investigation

Decision

on BC(s)

or

NONCONFORMING QC RESULTS - DECISIONS

PRODUCT REVISION

RESTRICTED USAGE

ACCEPTANCE OFNONCONFORMITY

DISCARD

OTHERS

Repeat testing according to quality protocol

e.g. in QC (influence on the result?)

Exceptional circumstances - properly explained and documented

product recalldonor counselingrepair of the equipmentstaff re-educationtesting of other components

BC NONCONFORMITY - INVESTIGATION

• causes• influence on other products from the same donation• influence on blood products from other donations of the donor• influence on the other blood components from the same “batch”

BC NONCONFORMITY - INVESTIGATION

Depends on the type of the nonconformityDonor- related factors• CBC parameters (HGB, WBC, PLT...)• lipemia• protein content• other laboratory findings..Collection/processing/storage• length of blood withdrawal• flow

- venipuncture technique (technician)- veins

• apheresis procedure: alarms and messages• filtration time, separation time• storage conditions

BC NONCONFORMITY - INVESTIGATION

Equipment• HGB determination system• blood mixers• sealers/SCD• apheresis machines• blood centrifuges and separators• refrigerators/freezers...Materials• blood bags• filters• solutions• labels/adhesives...Human errors

ERRORS IN TRANSFUSION MEDICINE

• one of the leading causes of morbidity and mortality associated with transfusion therapy• may have disastrous consequences for the patients• frequently of multifactor nature

• danger of serious/fatal outcomes• cost of lost products

CAUSES OF ERRORS

• inexperienced staff• lack of staff• lack of knowledge• complexity of procedures• inappropriate design of equipment and procedures• poor communication• poor co-ordination• improper documentation• stress• distractions...

Even well trained individuals are at risk of making serious errors while working in poorly designed systems (Singh H et al. Qual Saf Health Care. 2006)

INVESTIGATION OF ERRORS/EVENTS

Datacollection

ClassificationAnalysis

CA/PAQuality

improvement

Formal protocol (e.g. MERS-TM)Responsible professionalsFocus on system-based issuesRisk assesment

Uniform

• systematic, comprehensive, efficient

SHOT/MHRA

• 3326 total reports• 2905 errors = 87.3%• 1667 no harm (1451 near miss + 216 right blood right patient)

S Narayan (Ed) D Poles et al. on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group. The 2018 Annual SHOT Report (2019).

SHOT - 2018

MHRA - 2018

• 1606 reports• 408 SAR • 1198 SAE (98.3% human errors)

MHRA = Medicines and Healthcare products Regulatory Agency

EC – SAE ANNUAL REPORT 2017

Human error68.7%

Other19.3%

Product defect4.9%

Equipment failure14.9%

Ref. Ares(2019)1077383 - 21/02/2019

EC. Summary of the 2017 annual reporting of serious adverse reactions and events for blood and blood components (data collected from 01/01/2016 to 31/12/2016)

Human error73.0%

Other7.2%

ERROR PREVENTION

• establishment of such an organizational structure and working environment where recognized errors can be reported without fear

• the use of simple, clear and intelligible documentation• initial and continuous education• defining critical sites in the work process and intensified surveillance of these sites

ERROR PREVENTION

• use of SOPs• clear rules and policies• systematic analysis of nonconformities, errors, complaints, and implementation of corrective

and preventive measures• internal audits • automation and computerization• checklists• duplicate checks• suggestions to be more careful – low potential

ERROR PREVENTION – TRANSFUSION MEDICINE

In addition to already mentioned preventive measures:• avoidance of unnecessary transfusions• identifications bracelets• radiofrequency ID systems• fingerprint sensors• palm vein scanning technology• blood testing at bedside• double grouping• transfusion registry• careful monitoring of the recipient• Haemovigilance systems

ERROR MONITORING

• important quality indicator• trend analysis• quality objectives• UCL (upper control limit)

0,18

0,24

0,14

0,07

0,16

0,18

0,11

0,19

0,13

0,18

0,21

0,09

0,00

0,05

0,10

0,15

0,20

0,25

0,30

1 2 3 4 5 6 7 8 9 10 11 12

%

months

ERRORS

% cilj GKG

Error monitoring: example CITM

COMPLAINT MANAGEMENT

• some products and services fail to meet the customer requirements/expectations, in spite of:- maximal institution commitment to quality - optimal results of internal quality measurements

• efficient complaint management provides valuable information on:- customer satisfaction- perception of the product and service quality

• precondition for undertaking appropriate CAPA and continuous quality improvement • tool for continuous quality harmonization with customer requirements and expectations

COMPLAINT MANAGEMENT

• clearly defined• described in a document defining:

- the course of activities - the persons responsible for their performance

COMPLAINT MANAGEMENT

• complaint receipt• complaint processing (analysis)

- justifiability- risk level

• informing the complainant on the activities performed and results obtained• implementation of corrective/preventive actions• periodical statistical analysis of data produced by the procedures of complaint management • monitoring efficiency of the corrective actions undertaken for complaints

COLABORATION WITH CUST OMERS

• partnership• good communication• proposals, suggestions, needs• important in the process of complaint management

COMPLAINT MANAGEMENT

DOMAIN project:• system of donor complaint management has been established in the majority of transfusion

institutions• the number of complaints received varies considerably among institutions

- waiting time- inappropriate staff communication- donor deferral- technique of venipuncture

Northern Ireland Blood Transfusion Service• annual 2017 report• 17 formal complaints out of 54954 donations

COMPLAINT MANAGEMENT

NHS Scotland Complaints Statistics 2014/15, Publication date – 29 September 2015 A National Statistics Publication for Scotland

• Scottish National BTS – donors• around 204,000 donors• 97 complaints per 100,000 attendances at blood donation services• 281 complaints (total) in 2008/09 (peak)• 231 complaints in 2011/12

- donor selection/health and safety- donor communications- staff attitudes and behavior- waiting times

COMPLAINT MANAGEMENT

• Croatian Institute of Transfusion Medicine (CITM)• 13-year period (1998-2010)• ~ 1 million donations• ~ 2.5 million blood components• laboratory testing performed in 600,000 patients• 817 complaints

Vuk T, et al. Management of complaints in blood establishments – thirteen year experience of

Croatian Institute of Transfusion Medicine. Blood Transfus 2012;10:302-10.

COMPLAINT MANAGEMENT – CROATIAN EXPERIENCE

Complaint category n %

Positive direct antiglobulin test (DAT) in RBC products 334 40.9

Blood product distribution/issuing 105 12.9

Blood product quality 77 9.4

Laboratory test findings 69 8.4

Blood product labeling 59 7.2

Bacterial contamination of blood product suspected 48 5.9

Transfusion virus transmission suspected 31 3.8

Providing service to donors 21 2.6

Providing service to patients 20 2.4

Other 53 6.5

Total 817 100.0

CITM 1998-2010

PRODUCT RECALL - CHARACTERISTICS

• efficient system• timely recall• products that are known or suspected of being nonconforming• questionable quality and/or safety• complete traceability throughout the transfusion chain

PRODUCT RECALL

• as soon as possible• at any time

• written procedure- all activities- degree of responsibility of each individual involved- harmonized with the existing professional standards and legal provisions

PRODUCT RECALL - REASONS

• PDI (donor risks)• aberration from the prescribed product/service quality detected upon issuing• results of donor testing may suggest possible risk of issued blood components• reported AE/AR pointing to nonconformity of other products from the same donation/batch;• user's complaint;• when requested by inspection or respective regulatory bodies...

PRODUCT RECALL - FREQUENCY

• relatively frequent in transfusion medicine- biological origin of blood products- specific risks associated with their use- not all risks can be predicted, some of them cannot be prevented

• 1/ 700 units available to hospitals (1990-1997) – Ramsey & Sherman 1999• 1/ 2,000 units in US in the late 1990s (Ramsey G, 2004)• 1/ 250 BC involved in market withdrawals and quarantines, 1/5800 formaly recalled

(Ramsey G, 2014)

RECALL INITIATED BY SUPPLIERS

Recall of:• equipment• reagents• other incoming materials

Procedure:• written instructions• responsible persons• etc...

NONCONFORMITIES OF MATERIALS AND EQUIPMENT

• timely detection, labeling and separation (putting out of use) of nonconforming materials/equipment

• assessment of the effect of nonconforming materials/equipment on product and service quality

• properly documented• supplier/manufacturer should be contacted• whenever possible, defective incoming material should be sent to the manufacturer • report to the CA/regulatory bodies as appropriate• evaluation and selection of manufacturers• good collaboration with the manufacturers

CONCLUSIONS

• timely detection of quality problems• comprehensive analysis and risk assessment• structured protocol• properly documented• monitoring trends• implementation of corrective/preventive actions• quality improvement• continuous process• team work

THANK YOU!