Counting the Cost of the Preanalytical Phase -

Worldlab 2011, Berlin

‘‘Counting the Cost of the Preanalytical PhaseCounting the Cost of the Preanalytical Phase’’

•• The Impact of Preanalytical Errors on Patients Treatment:The Impact of Preanalytical Errors on Patients Treatment:

Prof. G. Lippi, Prof. G. Lippi, Universitaria di Parma, ItalyUniversitaria di Parma, Italy

•• Understanding the Cost of the Preanalytical Phase in an OutpatiUnderstanding the Cost of the Preanalytical Phase in an Outpatient Setting:ent Setting:

Dr. G. Dr. G. SoffiatiSoffiati, , Ospedale ʺS. Bortoloʺ, ItalyOspedale ʺS. Bortoloʺ, Italy

• Discovering the Opportunity Cost of Preanalytical Errors:Discovering the Opportunity Cost of Preanalytical Errors:

Prof. M. Nauck, Prof. M. Nauck, University Hospital GreifswaldUniversity Hospital Greifswald, GermanyGermany

•• Questions & DiscussionsQuestions & Discussions

•• CoCo‐‐chairschairs Prof. M. Prof. M. PlebaniPlebani & Prof. V. & Prof. V. PalickaPalicka

WORLDMEDLAB 2011 BerlinWORLDMEDLAB 2011 BerlinISW # 32ISW # 32


The Impact of Preanalytical Errors on The Impact of Preanalytical Errors on

Patients TreatmentPatients Treatment

Prof. G. Prof. G. LippiLippiUniversity HospitalUniversity Hospital

Parma,Parma, ItalyItaly



Preanalyticalerrors

PreanalyticalPreanalyticalerrorserrors




Clinical ChemistryLaboratory


The consequences of laboratory errors might often be serious, especially for those related to specialised tests, as these are often considered as ‘diagnostic’. Thus, patients might be diagnosed with a particular disorder,when in fact they don't have it (i.e., ‘falsepositive’ test result is obtained), or else apatient with a true disorder might be missed(i.e., ‘false negative’ test result is obtained),both circumstances jeopardizing the patient health and producing unnecessary costs tothe healthcare system.






Economical impact of repeating blood collectionEconomical impact of repeating blood collection

Group n. of tubes / year

Group 1 3,5000,000

Group 2 800,000

Group 3 400,000

Group 4 100,000

% of repeated collection

Group 1 Group 2 Group 3 Group 4

2% $7,000 $1,600 $800 $200

5% $17,500 $4,000 $2,000 $500

10% $35,000 $8,000 $4,000 $1,000

15% $52,500 $12,000 $6,000 $1,500

20% $70,000 $16,000 $8,000 $2,000

Economical impact of repeating blood collection:

n. of tubes ____ x repetition of tube % = _______ x $0,10 = overall expense for repeating blood collection.


Academic Hospital of Parma ‐ 1400 beds

‐ 350,000 outpatients

2,400,000 tubes/year

2 to 3% sampling repetition



2% $7,000 $1,600 $800 $200

5% $17,500 $4,000 $2,000 $500

10% $35,000 $8,000 $4,000 $1,000

15% $52,500 $12,000 $6,000 $1,500

20% $70,000 $16,000 $8,000 $2,000

= $ 6,000




2% 17.500 hours 4.000 hours 2.000 hours 500 hours

5% 43.750 hours 10.000 hours 5.000 hours 1.250 hours




n. of tubes ____ x repeated collection % = _______ x 15 min*/60 = hours lost for repeating collection.

Impact of repeating blood collection on the personnelImpact of repeating blood collection on the personnel




2% 17.500 hours 4.000 hours 2.000 hours 500 hours





Academic Hospital of Parma ‐ 1400 beds

‐ 350,000 outpatients

2,400,000 tubes/year

2 to 3% sampling repetition

= 15,000 hours lost


Understanding the Cost of the Preanalytical Understanding the Cost of the Preanalytical

Phase in an Outpatient SettingPhase in an Outpatient Setting

Dr. G. Dr. G. SoffiatiSoffiati,,Hospital ʺS. Bortoloʺ, Hospital ʺS. Bortoloʺ,

VicenzaVicenza , Italy, Italy



Preanalytic phase in the diagnosticprocess (% of work)

20%

37%

25%

14%4%

Preanalytic phase outof the laboratory

Preanalytic phase inthe laboratory

Analytic phase

Post analytic phase

Transportation

G. Guder et al. 2001


Documents

Much literature is available about preanalytic phase

Much literature is available about blood collection technique

There are no documents about management and organization of clinics and blood collection points


Organization and network of ClinicalLaboratories in Italy

• Public Laboratory– In the hospital

• Inpatients• Outpatients

• Private Laboratory– In the hospital

• Inpatients• Outpatients

– Out of the hospital• Outpatients

• Public Laboratories are more widespread in Northern Italy, while private outpatients laboratories are widely present in South.


Location of clinics and points ofblood collection

• Hospitals– Laboratory clinics– Integrated laboratory– Day service clinics

• Ex hospitals• Districts• Extra hospital policlinics• Retirement home• Care centers• Private clinics• Private policlinics • GP• At home service• Shopping centers


Personnel in clinics and bloodcollection points

• Doctors• Nurses• Assistants• Administrative personnel• Sanitary operators• Technical operators

Certified Phlebotomists


Activities in clinics and bloodcollection points

• With booking service• Without booking service • From Monday to Friday• From Monday to Saturday• Administrative check in office • Laboratory check in office • Informed Approval – Informative note (privacy)• Cashier service• Vein blood collection• Functional tests• Biological material delivery • OAT monitoring


Materials in clinics and bloodcollection points

• Blood collection system • Sanitary materials (cotton, disinfecting liquid, tourniquet, etc.)• Drugs• Informative System

– LIS– HIS– Software for booking office– Dedicated software, linked with LIS

• Robot for tube labelling and traceability


Management of clinics and collectionpoints

Clinic directors

Health directors

Booking office

District directors

Outsourcing

Social cooperative.


NN°° BedsBeds:: 827827

AdmissionsAdmissions//yearyear:: 40,00040,000

WardsWards:: 4545


Productivity per year

0500,000

1,000,0001,500,0002,000,0002,500,0003,000,0003,500,0004,000,0004,500,0005,000,000

1995 1997 1999 2001 2003 2005 2007 2009

TOTAL Vicenza Noventa Sandrigo

# of

Test

sClinical chemistry and Haematology LaboratoryS. Bortolo Hospital, Vicenza


Number of outpatients per year

131496 136768150580155847

189891 195567204491

215519224542 225084 220093

240595256276 257585

272831281443 285056

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

Clinical chemistry and Haematology LaboratoryS. Bortolo Hospital, Vicenza

# of

outp

atie

nts


Laboratory specimen acceptabilityClinical chemistry and Haematology LaboratoryS. Bortolo Hospital, Vicenza


Laboratory specimen acceptability






€ 229.282; 3%

€ 738.479; 10%

€ 3.002.190; 39%€ 1.013.431; 13%

€ 691.203; 9%

€ 469.163; 6%

€ 808.884; 11%

€ 691.193; 9%

COSTO PER SETTORE (annuale)

PRE ‐ ANALITICA

PUNTI PRELIEVO

CORE LAB

FARMACOLOGIA ‐TOSSICOLOGIA

IMMUNOMETRIA

PROTEINE

URINE‐AUTOIMMUNITA'‐ALLERGOLOGIA

GESTIONE E SERVIZI

Break down of Laboratory CostsVicenza Lab

Yearly costs per speciality

Bloodcollectionpoints


BENCHMARKING

““IL BENCHMARKING NEI IL BENCHMARKING NEI LABORATORI LABORATORI DIDI

PATOLOGIA CLINICA: PATOLOGIA CLINICA: LL’’ESPERIENZA ESPERIENZA DIDI UN UN

PROGETTO NAZIONALEPROGETTO NAZIONALE””yearyear 20082008

Benchmarking in Clinical pathologylaboratory: theexperience of a national project


Participants

13

571

North Italy

5

131

CentralItaly

202Total

60> 3.000.0001001.000.000 – 3.000.000

42< 1.000.000TotalSouth

Italy# of tests/year


Participants

13

30

10

North Italy

5

113

CentralItaly

202Total

40Policlinics10Pediatrics

152Hospital and Territory

TotalSouth ItalyData collected from

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

V B C D E F G HI L M N

Number of Patients per structure

Participants

# of

Patie

nts


Number of tubes per patient

# of specimens per patient


Patients per personnel working hour

# of patients per personnel working hour


Cost per patient

Euro


8%18%

89%

27%16% 11%

72%

92%82%

100%

73%84% 89%

28%

100%

0%

11%0%

A B C D E F G H I

Material Personnel

Ratio between material and personnelcosts


0

500

1000

1500

2000

2500

3000

3500

4000

V B C D E F G H I L M N0

2

4

6

8

10

12

PrelievoLaboratorioPercentuale

Blood Collection Costs vs Total Costs LAB


BOCCONI UNIVERSITY- MilanBenchmarking Veneto Region (2010)

Gruppo Linea Standard Volumi

Media semplice di linea std

Media ponderata di linea std

Media trimmata di linea std

Prelievo Prelievo 733.887 11,04€ 7,01€ 7,38€ Chimica Clinica (Endocrinologia) Immunometria 2.400.185 10,08€ 9,14€ 9,73€

Chimica clinica e metabolismo 13.623.542 1,48€ 1,29€ 1,29€ Farmacotossicologia ed esoterici 1.904 25,95€ 29,01€ 29,01€ HPLC Spettrometria di massa 130.854 13,70€ 9,37€ 10,27€ Proteine ed elettroforesi 905.296 5,10€ 4,24€ 4,24€

Ematologia Citoflorimetria 77.550 11,37€ 6,54€ 6,54€ Coagulazione 1.660.139 5,56€ 2,90€ 2,80€ Emocitometria 1.751.530 3,35€ 3,03€ 3,12€ VES 344.560 2,45€ 2,14€ 2,13€

Microbiologia clinica Batteriologia 413.789 17,94€ 18,77€ 18,40€ Micologia 4.790 14,04€ 12,75€ 12,02€ Parassitologia 26.103 13,49€ 21,42€ 21,48€ Sierologia 708.316 9,11€ 11,08€ 10,79€ Virologia 80.651 28,45€ 40,24€ 41,14€

Patologia clinica Calcoli 871 10,91€ 9,75€ 13,87€ Feci 64.316 7,09€ 5,55€ 5,66€ Liquidi biologici 10.384 13,13€ 21,79€ 7,10€ Urine 583.632 4,54€ 4,00€ 3,69€

Immunologia clinica Allergologia 5.285 17,59€ 21,32€ 21,32€ Autoimmunologia 36.498 20,87€ 21,00€ 19,58€

VolumeTrimmedaverage

Standard line

WeightedaverageAverage

Group

Blo

odco

llect

ion

Cost/speciality


BOCCONI UNIVERSITY- Milan Benchmarking Veneto Region (2010)

€ - € 5,00 € 10,00 € 15,00 € 20,00 € 25,00 € 30,00 € 35,00 € 40,00 € 45,00

Prelievo

(Endocrinologia) Immunometria

Chimica clinica e metabolismo

Farmacotossicologia ed esoterici

HPLC Spettrometria di massa

Proteine ed elettroforesi

Citoflorimetria

Coagulazione

Emocitometria

VES

Batteriologia

Micologia

Parassitologia

Sierologia

Virologia

Calcoli

Feci

Liquidi biologici

Urine

Prel

ievo

Chi

mic

a C

linica

Emat

ologi

aM

icrob

iolo

gia

clin

ica

Pato

logia

clin

ica

Costo Beni Costo personale Costo tecnologia Costo pre-analitica Costo post-analitica Costo Comuni e Indiretti Costo GeneraliBloo

dco

llect

ion

Comparison between the cost of collecting blood samples and other categories of tests


BOCCONI UNIVERSITY- Milan Benchmarking Veneto Region (2010)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Prelievo

(Endocrinologia) Immunometria

Chimica clinica e metabolismo

Farmacotossicologia ed esoterici

HPLC Spettrometria di massa

Proteine ed elettroforesi

Citoflorimetria

Coagulazione

Emocitometria

VES

Batteriologia

Micologia

Parassitologia

Sierologia

Virologia

Calcoli

Feci

Liquidi biologici

UrinePr

elie

voC

him

ica

Clin

ica

Emat

olog

iaM

icro

biol

ogia

clin

ica

Pato

logi

a cl

inic

a

Costo Beni Costo personale Costo tecnologia Costo pre-analitica Costo post-analitica Costo Comuni e Indiretti Costo Generali

Blo

odco

llect

ion

Cost components


BOCCONI UNIVERSITY- MilanBenchmarking Veneto Region (2010)

0%

20%

40%

60%

80%

100%

Prestazioni obsolescenti

Genetica

Immunologia clinica

Biologia Molecolare

Patologia clinica

Microbiologia clinica

Ematologia

Chimica Clinica

Prelievo

Blood collection

Comparison the cost of each individual laboratory speciality

Attending Labs


Conclusions

• Of course the quality of the data collection to evaluate the aspects considered in this presentation should be improved.

• The methods used to manage the collection of blood samples is very diverse in the different laboratories we considered.

• This activity, blood collection, is often not taken into account in assessing the overall costs of the laboratory.

• This activity, blood collection, has relevant economic impact. It is important to agree whether it should be included within the budget of the laboratory

• Is the general belief claiming “we can save money by consolidating labs”really true? The reality is that most analyses do not take into account the cost of collecting blood samples to come to this conclusion.

• And finally, in a consolidation setting, what is and what will be the quality of our samples?


Thanks

This is not a bloodsample, thisis a patient

Caring is theguaranteefor betterresults


Discovering the Opportunity Cost of Discovering the Opportunity Cost of

Preanalytical ErrorsPreanalytical Errors

ProfProf.. M.M. NauckNauckUniversity Hospital GreifswaldUniversity Hospital Greifswald,

GermanyGermany



Costs in German Health Care


Preanalytical Phase – Why do we care?

Costs

RiliBÄK 2008

Patient safety

Most errors occur outside the lab1, 2

Reputation

• 1 Plebani M & Carraro P. Mistakes in a Stat Laboratory: types and frequency. Clinical Chemistry 1997, 43(8): 1348-135.• 2 Carraro P & Plebani M. Errors in a Stat Laboratory: types and frequency 10 years later. Clinical Chemistry 2007, 53(7): 1338-1342.


Case report I - noticed

Adult twins with very similar names

Both had been in our hospital before

One was admitted with diagnosis stroke

Admission under twin brothers´ name

Noticed after several days (visitors)

Among others all lab results were reported under wrong patient

No severe consequences for patient – fortunately

Due to kind of error wristband was wrong as well


Case report II - noticed

Patient, female 51 years: Immunofixationelectrophoresis positive, no previous results available

Rerun of test after a few days(confirmation)

Immunofixation electrophoresis negative

Further reruns with fresh blood samplesgave also negative results

Next step: who was positive in the first place?

Patient in question had already been releasedand had to be called back in.


„Case report“ - unnoticed

Big number of rare mistakes

Various number of constantly re-occuring preanalytic mistakes, e.g.

Noticed (lab and ward) patient mix-ups occur several times a week

24h urine collection patient mix-up

Blood collection while intravenous-drip is still running

Wrong material e.g. plasma instead of serum for serum protein electrophoresis

Prolonged or wrong transportation (ammonia, glucose)


Approaches to quantify costs

Bottom-up approach

versus

Top-down approach

total costs of errors

Top: total costs of hospital

estimate cost of each error and addover estimated errors

estimated frequency of errors

estimated severity of errors

errors costs as % total hospital costs

wrong

Bottom: single errors


Cost Model estimates Opportunity costs

Costs that could have been saved if

the sample had not been rejected

due to preanalytical reasons.


Top-down approach

No need to chase single errors in a complex process

Decreased risk of over estimation of single error

No need to address all individual costs

but:

motivation of participants plays important role (positive and negative)

€ etc.+€ sample transport+€ consumables+€ work time


Cost Model

Developed by Frost & Sullivan and BD Diagnostics, Preanalytical Systems

Model estimates opportunity costs

Cost of hospital stay per patient and hour

Delay in procedures caused by errors

Costs of preanalytical errors in lost treatment hours and money

annual cost

number of patients

number of beds

number of repeatedblood collection

in different scenarios



Assumptions for the model

Restriction to repeated blood collection

100% utilisation of hospital and laboratory are assumed

Patients are categorised into three groups

Impact of a preanalytical error classified into three levels

Motivation of participants is neutral


Patient Categories

Critical care unit

Stationary non-critical patients

Out-patients


Impact of preanalytical errors

Low impact

Medium impact

High impact

“Best Case”

The error is spotted early in the process and a repeated blood collection is initiated.

“Medium Case”

The error is not spotted immediately, but there are no substantial consequences for the patient. Wrong results have been reported, no consequence for patient, redraw is initiated.

“Worst Case”

The error is only spotted after the patient was affected severely.


Cost Model – Strengths and Weaknesses

No detailed information about causes

Interview method can be biased

Quick and easy mandatory for compliance

Good estimate of magnitude


Greifswald

First application of model on basis:

one critical care unit

one regular ward

one ambulatory ward


Greifswald

0.08162mean

3 wards

% of total costCosts/bed/year €


Greifswald

0.19391Mean

34 wards

0.08162mean

3 wards



Greifswald

0.972025Worst case

0.0246Best case

0.19391Mean

34 wards

0.08162mean

3 wards



Cost Model – Results

7 hospitals in Europe and US (2008 – 2011)

Heterogeneous group of hospitals (e.g. 300-1500 beds)

Minimum MaximumMedian

Source: Frost & Sullivan, BD Diagnostics

49 € 2537 €185 €Error costs per bed and year

Error costs in % of total hospital costs0.05 % 0.10 % 0.82 %

162 €

0.08 %

391 €

0.19 %


Thank you for your attention!


QuestionsQuestions & & DiscussionsDiscussions

ProfProf. V. . V. Palicka, Palicka, University Hospital, Hradec University Hospital, Hradec KrKráálovlovéé, , Czech RepublicCzech Republic

Prof. M. PlebaniProf. M. Plebani, , University Hospital of University Hospital of PadovaPadova, Italy , Italy
