QSE Analysis By Beth Luman

Acknowledgements:

Robert Maina, Bernard Nkrumah

Linda Andiric, Rosemary Audu, Laura Eno, Thomas Gachuki, Giselle Guevara,

Tilahun Hiwotu, Adino Lulie, Ernest Makokha, Talkmore Maruta, Phidelis Maruti, Jessina

Masamha, Mary Mataranyika, Kelebeletse Mokobela, Juliana Ndasi, Thuong Nguyen,

Siyem Nkwawir, Michael Noble, Keoratile Ntshambiwa, Innocent

Nzabahimana, Phoebe Nzombe and Edwin Shumba

Katy Yao, John Nkengasong

12 Quality System Essentials

• SLIPTA checklist

12 Quality System Essentials Quality Cycle

12 Quality System Essentials SLIPTA Score

0

20

40

60

80

100

Documents and

Records

Management Reviews

Organisation and

Personnel

Client Management

and Customer Service

Equipment

Maintenance

Internal Audit

Purchasing and

Inventory

Process Control,

Internal and External

Quality Audit

Information

Management

Corrective Action

Occurrence

Management

Facilities and Safety

Baseline

Bernard Nkrumah et al.

12 Quality System Essentials SLMTA Improvement

0

20

40

60

80

100

Documents and

Records

Management Reviews

Organisation and

Personnel

Client Management

and Customer Service

Equipment

Maintenance

Internal Audit

Purchasing and

Inventory

Process Control,

Internal and External

Quality Audit

Information

Management

Corrective Action

Occurrence

Management

Facilities and Safety

Baseline

Exit Audit

Bernard Nkrumah et al.

What are the areas that laboratories struggle with? What are the areas that they do well with? Which areas do they improve through SLMTA? • QSE’s not systematically compiled on a global scale

• Literature Review • 126 labs in 12 countries • Meta-analysis

• Results • Lots of variability

• For the 5 QSE’s that at least 1 lab scored 0% at exit, some other lab scored 100%

• Lots of similarities

What are the areas that laboratories struggle with? What are the areas that they do well with? Which areas do they improve through SLMTA?

39

47

39 42

40

27

51

41

25

8

29

16

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Info

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Pro

cess

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IQC

/EQ

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Co

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tive

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Inte

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Man

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revi

ews

Occ

urr

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man

agem

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Resource management Process management Improvement management

Per

cen

t Sc

ore

Quality System Essentials grouped in overall categories

Baseline audit

What are the areas that laboratories struggle with? What are the areas that they do well with? Which areas do they improve through SLMTA?

39

47

39 42

40

27

51

41

25

8

29

16

59

74

62 63

69

61 64

58

50

32

48

38

0

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Equ

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Faci

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Org

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nd

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Clie

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Do

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d r

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Info

rmat

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man

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ent

Pro

cess

co

ntr

ol/

IQC

/EQ

A

Co

rrec

tive

act

ion

Inte

rnal

au

dit

s

Man

agem

ent

revi

ews

Occ

urr

ence

man

agem

ent

Resource management Process management Improvement management

Per

cen

t Sc

ore

Quality System Essentials grouped in overall categories

Baseline audit

Exit audit

What are the MOST CRITICAL improvements for laboratories to make?

• What is your goal? • Increase my score

• To make other improvements easier

• To give quick success and boost morale

• To increase respectability -- patients and providers

• Reduce errors

• Reduce healthcare costs

• Improve patient outcomes

Option 1…

• 3 experts decide which projects should be done

Option 2…

• 100 labs that have implemented SLMTA

• Ask implementers which improvement projects they thought were the most productive

Option 3…

• 20 potential improvement projects

• Select 200 labs and randomly assign each project to 10 labs

• Analyze all of these potential goals

• Repeat for combinations of improvement projects

Option 4…

• Examine labs that improved more and those that improved less

• Which QSE’s best explain the difference

• GOAL: Increase my score

Option 4…

Which QSE’s were associated with the biggest improvement in overall score?

• Sort labs by SLIPTA score improvement

• Compare most improved to least improved • What was the change in score for each QSE? • What was the difference in change of score for each QSE among

the most improved vs. least improved?

• Does this explain all of the difference between most improved and least improved? • What was the change in scores excluding the critical QSE? • How might this QSE explain the differences?

Example 1: Maina et al

30

80

32

52

37

75

85

57 60

77

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Lab A Lab B Lab C Lab D Lab E

Pe

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Exit Surveillance

Example 1: Maina et al

30

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57 60

77

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Lab A Lab B Lab C Lab D Lab E

Pe

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Exit Surveillance

40% 8%

25% X 45%

Example 1: Maina et. al. A+E exit surv improvement

diff improvement

between ae and cd

Documents & Records 32 80 48 8

Management Reviews 21 53 32 51

Organization & Personnel 45 75 30 30

Client Management & Customer Service 25 81 56 6

Equipment 30 68 38 27

Internal Audit 0 60 60 50

Purchasing & Inventory 48 88 40 10

Process Ctrl &IQC/EQA 36 77 41 8

Information management 25 78 53 45

Corrective Action 4 58 54 77

Occurrence/Incidence Management & Process Improvement 13 54 42 48

Facility & Safety 50 92 42 26

30 78 48 total without internal audit and corrective action

C+D

Documents & Records 26 66 40

Management Reviews 48 29 -19

Organization & Personnel 55 55 0

Client Management & Customer Service 19 69 50

Equipment 45 57 12

Internal Audit 0 10 10

Purchasing & Inventory 47 77 30

Process Ctrl &IQC/EQA 42 74 32

Information management 40 47 8

Corrective Action 35 13 -23

Occurrence/Incidence Management & Process Improvement 14 8 -6

Facility & Safety 69 85 16

42 57 15 total without internal audit and corrective action

Example 1: Maina et. al.

Progressing beyond SLMTA: Are internal audits and corrective action the key drivers of quality improvement? Afr J Lab Med 2014.

Example 2: Lit Review

Example 2: Lit Review • Meta-analysis results suggest that the corrective action QSE

may be the most predictive of overall improvement

• Laboratories in the top quartile of overall improvement outperformed those in the bottom quartile by 62 percentage points for the corrective action QSE, compared to a median of 40 percentage points for the other QSEs.

• CLSI defines corrective action as an ‘action to eliminate the (root) cause of a detected nonconformity or other undesirable situation’.

• In the SLIPTA checklist, corrective action is assessed through four questions about how the laboratory deals with occurrence reports, nonconformities and discordant results.

• ISO confirms the importance of corrective action, saying that ‘the corrective and preventive actions system is the most critical element for an efficient quality system’.

Considerations

• This is a simple analysis

• Other possible analyses with multivariate models

• Observational vs. experimental • Confounding factors

Most importantly…

• This only examines one of the many goals – increase my score

• Ultimate goal – improve patient outcomes