LabInsight Workflow Optimization for Quality Control ... 24/SalaA3PDF/14_00-15_25...94.204 Congreso Nacional Laboratorio Clínico 2018 . From care to research The presence of professional

LabInsight Workflow

Optimization for Quality

Control – practical

experience

Dr. Stefano Pastori

Responsabile Struttura Semplice Biochimica Clinica

ASST Grande Ospedale Metropolitano Niguarda

Milan - ItalyCongreso Nacional Laboratorio Clínico

2018

About us

The main goal of Niguarda is to combine specialised care and health

social activity on the territory in order to meet all the healthcare needs of

the population.

Niguarda is a referral hospital for the city of Milan, in which it is located, for

Lombardy region and Italy as well.

Niguarda was opened in 1939, since then it

has undergone to a remarkable evolution

either structural and organisational.

The leading keys elements of it's

transformation are multidisciplinary

technology and integration.Congreso Nacional Laboratorio Clínico

2018

Highlights

• Transplant Center

• Burn Care Unit

• Tissue Bank

• Stroke Unit

• Trauma Team

• Antipoison Center

• Rare Diseases Center

• Equestrian Rehabilitation Center

• Unipolar Spinal Unit

• Headquarter of the 118 Emergency

• Helicopter service

Congreso Nacional Laboratorio Clínico

2018

Departments

• Cardio Vascular

• Multi specialist Surgery

• Hematology-Oncology

• EAR

• Mother and child

• Laboratory medicine

• Multispecialist medicine

• Neuroscience

• Mental health

• Advanced Diagnostic-

Therapeutic technologies


2018

Clinical activity **(2017)

BEDS

1.167

ADMISSIONS

31.506

DAY HOSPITAL

18.900

OUTPATIENT DEP.

2.438.320

ER ADMISSIONS

94.204


2018

From care to research

The presence of professional

skills, technological

competences, certified

laboratories and high

complexity patient cohorts,

make Niguarda

a point of reference for

collaborations with Universities

and national and international

Institutions.Congreso Nacional Laboratorio Clínico

2018

LabInsight Workflow Analysis

Based on Lean Six-Sigma methodologies


2018

8 Lean Waste

First step is

seeing the waste


2018

1. Over production 2. Waiting

3. Transportation 4. Over processing


2018

5. Inventory 6. Motion

7. Defects 8. Non utilized talent


2018

LabInsight-

1. Define the Objectives

DMAIC phases

2. Measure: Work Flow Study

3. Analyze 4. Improve and Control


2018

Reduce QCs aliquotes and associated

manual steps

Standardize and improve QCs management

in different Lab departments

Improve security: pre-analytical, analytical

and clinical (Risk Control)

Improve order process and inventory

OBJECTIVES: improve and standardize QC

in all Lab Dep


2018

Sections Analytical systems in use

CORELAB Integrated preanalytical line,

Chain with 2 Cobas-8000 Roche and

1 Cobas Integra-400 (stand alone)

COAGULATION 2 different analyzers 1 Sysmex CS 5100 and 1

Siemens BCS

HAEMATOLOGY Sysmex XN-9100™ Automated Hematology System

(4 analyzers on line) and 1 preparer, colorizer and

automatic slide reader.

2 VES Matic 2000 DIESSE

HAEMOGLOBIN EVALUATION

(HBA1C – VARIANTS)

1 Sebia Capillarys2

ELECTROFORESIS 2 Sebia Capillarys2

ALLERGOLOGY 1 Phadia 1000 Thermofisher

URINE Siemens Clinitec Atlas (tender in evaluation)Congreso Nacio

nal Laboratorio Clínico 2018

CURRENT SITUATION

CORELAB: TLA ROCHE

Pre-analitycal phase: TLA Roche NO QC

Analitycal phase:

2 Cobas8000 e 1 Cobas Integra

BioRad and Roche QCs

5h; 8h; 16h

TIME LINE QC CORELAB

Measure: Work Flow

Study


2018

CURRENT SITUATION

TIME LINE CORELAB: SAMPLES and QCs distribution in 24h

63% in 6 hours (1 QC)mean 158 sample/hour

37% in 18 hours (2 QC)mean 31 sample/hour

00:00 23:59

01:0002:00 03:00 04:0005:00 06:00 07:00 08:0009:00 10:00 11:0012:00 13:00 14:0015:00 16:00 17:00 18:0019:00 20:00 21:0022:00 23:00

05:00

QC

08:00

QC

14:00

QC

00:00 - 23:59

TOTAL SAMPLES 1.500

09:30 - 15:30

950 samples


2018

BIO-RAD CONTROL MAP: CORELAB Cobas 8000 1 e 2

Cobas Integracode Product 4h 5h 6h 7h 8h 9h 10h 11h 12h 13h 14h 15h 16h

661 LYPHOCHEK BENZO/TCA CONTR- SET A 1 1

* on Cobas2

code Product 4h 5h 6h 7h 8h 9h 10h 11h 12h 13h 14h 15h 16h

691 LIQUICHEK UNASSAYED CHEMISTRY 3 2

692 LIQUICHEK UNASSAYED CHEMISTRY 3 2

544 LIQUICHEK ETHANOL/AMMONIA LEV 1 1 1

545 LIQUICHEK ETHANOL/AMMONIA LEV 2 1 1

646 LIQUICHEK CARDIAC MARKERS LT Lev. 1 1 1

647 LIQUICHEK CARDIAC MARKERS LT Lev.2 1 1

12001084 CARDIAC TROPONINS 1 (hS per Roche) 1 1

367 LYPHOCHEK TUMOR MARKER PLUS 1 2 1

368 LYPHOCHEK TUMOR MARKER PLUS 2 2 1

370 LYPHOCHEK IMMUNOASSY PLUS TRILEVEL 4 2 * 2

364 LIQUICHEK SPECIALTY IA Liv.1 1

365 LIQUICHEK SPECIALTY IA Liv.2 1

594 LIQUICHEK IMMUNOLOGY Liv.1 1 1 1

595 LIQUICHEK IMMUNOLOGY Liv.2 1 1 1

355 LIQUICHEK PEDIATRIC LIV.II 1

751 SPINAL FLUID CTRL Liv.1 2 2

752 SPINAL FLUID CTRL Liv.2 2 2

376 LYPHO-CHEK QUANT.URINE LEVEL 1 1

377 LYPHO-CHEK QUANT.URINE LEVEL 2 1

466 LIQUICHEK URINE TOXI LEV.S1 1 1

467 LIQUICHEK URINE TOXI LEVEL S2 1 1

28 quote 8 quote 21 quote

73 aliquotes + 6 dilute lyoph. TOTAL 79

Bio-Rad QCs + Roche QCs


2018

CURRENT SITUATION: COAGULATION

744 LYPHOCHEK COAG. LIV.1

745 LYPHOCHEK COAG. LIV.2

Two systems: CS e BCS Siemens

Sistems are connected with Unity,

but QC validation is done on systems not on URT

PT, PTT, APTT e Fibrinogen

D-dimer QC Siemens


2018

CURRENT SITUATION: HEMATOLOGY

1.000 – 1.200 day

NO third party QC

04:30 16:00

04:30

ALL SYSTEMS

TURN ON

AND RUN QC

13:00

QC ON SYSTEMS 3 e 4

16:00

SYSTEMS 2 e 1

TURN OFF

TLA SYSMEX (Dasit): 4 systems

Two systems VES Matic200 Diesse: no third-party QCCongreso Nacional Laboratorio Clínico

2018

CURRENT SITUATION:

HEMOGLOBIN and ELECTROPHORESIS

553X HEMOGLOBIN A2 LYPH SP

740X DIABETES CTRL BILEVEL

1 SEBIA Capillary2

Controlled only 2/8 capillaries/day

QC value are manually load in Unity

2 SEBIA Capillary2

2 SEBIA Capillary2

NO THIRD-PARTY QC


2018

CURRENT SITUATION: ALLERGY

1 Phadia 1000 ThermoFisher

12000141 ALLERGEN SIGE NEG LYPH 6X2 ML

12000142 ALLERGEN SIGE PANEL A LYPH 6X2

QC Bio-Rad automatically connected to Unity.

NB: in Autoimmune Dep (1rst floor Lab) are using Bio-Rad QCs

in IFA on Euroimmune System


2018

CURRENT SITUATION: URINE SECTOR

Siemens Systems

435 LIQUICHEK URINALISYS BILEVEL

This sector will change globally

room and instruments


2018

ANALYSE AND IMPROVEMENT AREAS

CORELAB

Replace Lyphochek with Liquichek

cod. 370

cod. 360 Liquichek Immunoassay Plus Control

cod. 367 e 369

cod. 547 e 548 Liquichek Tumor Markers

(BIO-IMM + IMM-URG + Beta HCG)

Create new panels

Mon-Frid H5

RACK 002 POS 1 BIO-IMM 1

POS 2 BIO-IMM 2RACK 0011 POS 1 IMM-URG 1

POS 2 IMM-URG 2

Mon-Frid H16 ; Sat + Sun

(+ Beta HCG)

Reduction 10 manual steps


2018


Improve interlab

Unassayed Chemistry 691 e 692

Assayed Chemistry 694 e 695

Spinal Fluid in BIO-UR1 e 2

Lyphochek Quantitative Urine (+ BioAlbu)

Liquichek Cardiac Markers LT 646 e 647

Liquichek Cardiac Markers LT Plus 146 e 147

Improve interlab

Create new panels

Reduction 8 aliquotes and

CORELAB

57 aliquotes + 2 to dilute lyophil. TOTAL 59

16 aliquotes (1.6 ml dead vol.) 25%


2018


Standardize and Improve QCs validation phase

with UNITY Real Time

Use different UNITY Real Time client to divide validation

in panels/instruments and reduce time

Use the function “bench review” as instruction provided

(not paper insert)

Implement an operative strategy for systems automatic

alignement using QCI and Unity.


2018


SYSTEMS CS e BCS SIEMENS

Use UNITY Real Time to evaluate QCs data and

interlaboratory (Lyphochek Coagulation Control Lev1 e 2)

Implement new Control Lyphochek Hemostasis (cod. 597-

598) for Protein C and Protein S, currently not controlled.

Implement new Control Liquicheck D-dimer (cod.27101 -

27102) in place of the Siemens Control.

2 SYSTEMS VES-MATIC200 DIESSE

Implement new Control Liquichek Sedimentation Rate Control

(cod. 514 livello 1, cod. 515 liv. 2)

COAGULATION


2018


Connect Sysmex systems to Unity.

TRAIN ON UNITY REAL TIME TECHNICIANS

FOR COAGULATION AND HEMATOLOGY

SYSMEX TLA

Implement new third-party Controls:

Liquichek Hematology Control (X) cod. 487 trilevel

Liquicheck Reticulocytes Control (X) cod. 926, 927,

928 (choose)

HEMATOLOGY


2018


HEMOGLOBINE

Check all 8 capillaries daily

ELECTROPHORESIS

Implement new third-party Control usign Level 3

from Liquichek Immunoassay Plus

(not used in Corelab).

URINE

Postpone changes after moving in the new room

with new systemsCongreso Nacional Laboratorio Clínico

2018


CLINICAL RISK

Mission:ControlTM is a software that allow

to evaluate in use analytical methods and

instruments performances on the basis of

QCs results, evaluate current risk to

release patient results not correct, quantify

the possibility to reduce this risk on the

basis of instruments performances, select

rules and QCs frequency that fit better

with mission of the Lab, minimize the risk

to report aberrant results.Improve and ControlCongreso Nacio

nal Laboratorio Clínico 2018

Risk Calulator

QC Designer


2018


Example: with Mission:Control we calculated the Clinical Risk applying Risk Calculator

on tests GLUCOSE, CREATININE , PTH-INTACT and CEA .

Applying QC Designer we re-bilt the QC strategy with the objective to reduce risk

(ENuf<1)

ROCHE COOBAS8000 1:

(1500 patients/day with current QCI)

Programming QCI in more balanced way

in the middle of the patients

48% riskCongreso Nacional Laboratorio Clínico

2018


2018

CONCLUSION

Reduce QC quotes and manual steps

Replacing Lyphochek with Liquichek and removing some multiple aliquotes,

manual steps are reduced by 25% (and risk for error) and aliquotes by 16

units (from 73 a 57).

Implement third-party QC and URT in all Lab department

Implementing QCs Bio-Rad in Hematology and Electrophoresys,

managing QC data on URT in Coagulation, Electrophoresis and

Hematology, all Lab department have a standardize QC System.

Improve pre-analytical, analytical and clinical security

Implementing Serum Indices Controls. Applying Mission Control to

create Individual Quality Control Plans to monitor and reduce

Clinical Risk.

Improve order process and inventory

Implementing an Annual Order to maintain the same Lot number,

reduce error, avoid lack of product. Standardize the inventory using a

color code mode.


2018

IMPLEMENT AND CONTROL

Replace Liphochek

with Liquichek Started in September

New QC in hematology

New Serum IndicesWork in progress


2018


2018


PRE-ANALYTICAL PHASE

Liquichek Serum Indices cod. 12002290

4 x 4ml

Verify icterus, hemolysis, lipemia

and no interference

control the pre-analytical module

save time in the analytical phase

Analyze


2018

Next step:

Input:

UNITY DATA:

• Mean, DS, CV

• Wesgard Rules

• Analytical Goals (TE)

• Bias comparation: interlaboratory

LABORATORY:

• Number of patients

• Number of QC

• MTBF: Mean Time Between Failures in

days

CLINIC:

Severity of harm

Output:

Mission: Control quantifies the risk of patient harm with the

Risk Management Index (RMI).

RMI = Probability of Harm Predicted / Probability of Harm

Allowed

Allowable Harm

Risk of Harm the lab is willing to accept

Depends on analyte and type medical treatment

Calculated Harm

Based on scientific algorithms:

RMItotal = RMIbias + RMIimprecision + RMIout of control


2018

INPUT: OUTPUT:


2018

Thank for your attention

[email protected]


2018

Documents

LabInsight Workflow Optimization for Quality Control ... 24/SalaA3PDF/14_00-15_25...94.204 Congreso Nacional Laboratorio Clínico 2018 . From care to research The presence of professional