This document discusses the high-level operations of the clinical pathology laboratory at Changi General Hospital. It provides statistics on the hospital and increasing patient load. It also describes the laboratory's efforts to improve workflow challenges and ensure fast and accurate test turnaround times. This is achieved through streamlining pre-analytics, analytics, and post-analytics processes. Specifically, the laboratory focuses on batching and automation, stat test prioritization, extensive quality control, and automatic result verification to provide quality patient care.

2. Why should you
be concerned?

3. What ?
- High performance hematology
 Introduction
 Process
 Learning Points

4. 800-beds;
Opened 1997
2007
2005

5. A Day @ Changi General Hospital
3161 staff
384 doctors
800-beds 1451 nurses
85% occupancy
450-500
Emergency
attendances
1000-1500
Outpatient
attendances
10000-12000
Laboratory
investigations

6. Changi GH – Lab Medicine
Histopathology
Clinical Pathology
X 4930 / 4931
Hematology Transfusion
Microbiology
X 4935
Routine Microscopy
Immunoassay
Chemistry Urinalysis

8. Patient Load Increasing
Apr Apr Apr Apr Apr
2006 2007 2008 2009 2010
Emergency
(attendances) 11239 12885 13398 13871 13344
CLINICS
(outpatients)
25069 28325 30069 28665 28869

9. Increasing Clinical Pathology Workload
350
300
250
Tests (,000)
200
150
100
50
0
April 2007
April 2006 April 2007 April 2008 April 2009 April 2010

10. Workflow Challenges
 Batching, queuing
 STAT delays
 Review rates
 Transportation delays
 Reagent and instrument setup times
 Misplaced/misrouted samples
(how many, time to locate)
 Instrument downtime
 Slide generation
10 Put science on your side. ©2011 Abbott
Company Confidential

11. Keeping Good Time
Tests ER Ward Outpatients
FBC 12 (45’ – 98%) 15 (45’ – 97%) 15 (45’ – 99%)
INR 21 (45’ – 98%) 22 (45’ – 98%) 21 (45’ – 99%)
Renal 27 (45’ – 97%) 29 (45’ - 96%) 31 (45’ – 97%)
UrineA 9 (45’ – 99%) 10 (45’ – 99%) 12 (45’ – 99%)
TnT 33 (45’ – 92%) 35 (45’ - 96%)
HbA1c 21 (45’ – 99%)
Liver 33 (45’ – 96%)
Lipids 38 (45’ – 87%)

12. How ?
 Purpose
 Process
 People

13.  PURPOSE

14. ● Quality - high ● Results - fast & accurate
● Cost - reasonable ● Information – useful &
understandable
● Delivery - ASAP
● Therapy – direction
● Inconvenience - minimal
● Costs - not as important
• Technology - latest
• Risk - low

15. Rapid Results STATs
=
Improved Patient Care

16.  PROCESS
 How?
 Pre-analytics
Location
Sample - Order Entry, Tubes, Logistics
 Analytics
Sample – reception, processing
Testing platforms, automation
Right siting, right sizing
 Post-analytics
Results – autovalidation / enquiry / printing

17. Divider Title 2
How ?
1. Pre-Analytics
- test request
- sample collection
- sample transport

18. Test
Request
Individual Tests
Panels
Order Sets

19. Specimen
Collection
• Draw
• Sort
• Transport

21. Wards
Delivery time = 2 – 5 min
Clinics
ICU
ER
Lab

22. Divider Title 3
How ?
2. Analytics
- specimen processing
- analyzers
- lab layout
- staffing
? TLA

24. + HbA1c  20 / day }
+ ESR  10 / day } < 5% of 600 FBC/day
+ ESR + HbA1c  < 5 / day }

26. Individual Circuit Breaker for each instrument

27. Look for clots BEFORE analysis
+ HbA1c  20 / day }
+ ESR  10 / day } < 5% of total FBC
+ ESR + HbA1c  5 / day }

31. 1. Throughput Is Adequate
Workload: 300,000 FBC / year
700-900/day
600-780 day-time 100-120 after-hrs
100-120/hr @ peak periods

32. 2. Dynamic Range is Sufficient

33. 3. Precision is Good
Within-day
Day-day
Hb WBC
RBC PLT
High - cv 0.7% High - cv 1.9%
Normal - cv 0.9% High - cv 1.4% Normal - cv 2.1% High - cv 3.1%
Low - cv 1.0% Normal - cv 1.5% Low - cv 2.5% Normal - cv 6.2%
Low - cv 1.9% Low - cv 6.6%

34. 20

35. Low Normal High
WBC x 109/L
Ruby (n = 175) 2.51 (3.9%) 8.07 (2.6%) 10.67 (2.5%)
Sapphire (n = 146) 2.62 (3.9) 8.19 (2.3%) 10.87 (2.6%)
Hb x g/dL 6.45 (2.2%) 14.02 (2.0%) 18.77 (2.1%)
Platelets x 109/L 85.9 (6.7%) 197.7 (6.1%) 397.9 (4.8%)

36. 4. Reticulocytes
• Ruby reticulocyte method uses the thiazine dye New
Methylene Blue N.
• Assay performed in the WOC channel.
• Sample preparation is performed manually. 20ul blood
dispensed into a tube of Cell-Dyn reticulocyte reagent.
• Staining of reticulum is complete within 15 mins.
Stained sample is aspirated in the open mode.
• Reticulocytes are reported (%R).
• Absolute reticulocyte count calculated if RBC
concentration is entered.
Less than 5 requests per day

37. > 6 sigma is world-class; < 3.4 defects / million episodes
Ruby IQC RBC WBC Hb Platelet
Low 4.2 6.2 6.8 3.4
Normal 4.6 9.3 8.4 6.4
High 5.4 7.0 7.4 9.9
Sigma metric = (TEa – Bias) / cv > 4  -- 2 x 2 controls / day
-- one 2.5 s QC rule
TEa (total error allowable)

38. Fluid Cell type Normal Abnormal
CSF Leucocytes 0-5/µL >5/µL
Synovial Leucocytes <200/µL >200/µL
Erythrocytes <2000/µL >2000/µL
Pleural Leucocytes <1000/µL >1000/µL
Pericardial Leucocytes <1000/µL > 1000/µL
Peritoneal Leucocytes <300/µL >300/µL
Erythrocytes <100,000/µL >100,000/µL
Strasinger, S.K. (1985) Urinalysis and body fluids,
F.A. Davis, Philadelphia.

39. Extending
Dynamic Range
Initial triage of body fluid cell counts vs. microscopy:
Synovial (<200 WBC/uL) Pleural (<1000 WBC/uL)
Peritoneal (<300 WBC/uL) Pericardial (<1000 WBC/uL)
? CSF (<5 WBC/uL – adults; <30 WBC/uL – neonates)

47. 350 m2
A
A
B 20 m
B

49. Open Architecture . . . . .

51. Samples Received in a Day
250
200
Number of Samples
150
Public Holiday
Working Day
100
50
0
1
3
5
7
9
11
13
15
17
19
21
23
Time

52. Right Size
nights, weekends, public holidays

53. Divider Title 4
How ?
3. Post-Analytics
- critical lab values
- autoverification
Result Availability
- local printing
- intranet (lab)
- electronic medical record (EMR)

54. Hb (g/dL) <5 > 19.5 }
WBC (x 109/L) <1 > 50 } < 5 /day
Platelets (x 109/L) < 20 > 800 }
Johns Mayo UCLA MGH
Hopkins
Hb (g/dL) > 22 <6 > 20 < 6.5 > 18
WBC (x 109/L) < 1.2 > 30 < 1.0 > 100 < 1.0 > 50 < 2.0 > 50
Platelets (x 109/L) < 10 < 40 > 1000 < 20 > 1000 < 50 > 999

56. Middleware – enables Auto-verification
Success Criteria
• Senior Leadership drive and goal
• Repeated discussion of benefits
• Evidence based justification
• Taking small steps with proper checking
56

57. Critical Lab Values
5 / 19.5
1 / 50
20 / 800
Else Hold Back
Review 1:10

58. Continuing QA Validation
• Staff will regularly scroll through the data
manager (10%) for potential discrepancy
in results, note ID no., & sign document for
review by senior staff.
• Senior QA Co-ordinator will review and file
the documents.

59. No Hold Backs
No Flags

60. Middleware – Impact of Autoverification
Mean: 9 – 12 min
90th centile: 21-28 min
45 min TAT: 98.5 – 99.1%

61. Autoverification occurs in “middleware” server
 90% of results autoverified
 Faster turnaround time
 Increased capacity

62. Where Abbott Instrument Manager fits in
Laboratory Hospital
Information Information
System System
Ethernet
Additional Instrument
Instrument ManagerTM
ManagerTM Workstation
Workstation
No limitations
for added
workstations…
No limitations for
added
instrumentation…

63. Middleware – Instrument Manager
Improve satisfaction and reduce costs by decreasing human
errors and enabling quicker diagnosis
 View all sample information
Centralized Information  Select a sample to view
patient and test data
 Quick, accurate diagnosis
 Improve consistency
 Reduce training time  View patient
information
Automated Tasks
 Centralized, intelligent verification
 Manage
 Decrease human errors test results
 Standardize routine tasks (release, order
re-runs, etc.)
Simplified Quality
 Increase quality control
 Share data with QC software Adaptable Workspaces
 Utilize moving averages Customize windows, color code and filter data as needed
63

64. Redundancy Features
Back-Up
 LIS Backup
– Automatically print chartable reports
to ER and ICU printers during
downtime
– Print LIS downtime labels
automatically or on demand
– Complete audit trail for full
traceability
 Database backup
– Enables active mirror of Instrument
ManagerTM database
– Real time, continuous data backup
– Minimal downtime to failover

65. • Platelets > Hb > WBC
• Start by releasing ALL normal results + NO flags
Then ALL no hold backs + NO flags

66. Differentials
• WBC & RBC morphology flags
• Rules to decide manual differential or slide review

69. Location Apr2006 Jan2007 Feb2008 Mar2008
Wards 35’ 29’ 20’ 18’
SICU 27-40’ 36’ 21’ 19’
MICU 31-44’ 32’ 21’ 19’
Clinics 25’ 23’ 20’ 17’
ER 22-25’ 22’ 20’ 18’
Mean: 9 – 12 min
90th centile: 21-28 min
45 min TAT: 98.5 – 99.1%

70. Results Availability
 Printing @ source  Web Query
- LIS
- EMR (electronic
medical record)

74. Bonus - Remote Diagnostics
 Maximum equipment uptime
Benefits
 Fix it before it breaks
 Faster response time
 Engineers arrive with
the right parts
Monitor Instrument
Events and Alarms
 Early error detection
 Remote troubleshooting
 Proactive on-site visit
74

75. Bonus - Reagent Management System (RMS)
75 Put science on your side. ©2010 Abbott Company
Confidential

77. Workflow Challenges
 Batching, queuing  Process ASAR
 STAT delays  Pneumatic Tubes, ASAR
 Review rates  Autoverification
 Transportation delays  Pneumatic tubes
 Reagent and instrument setup times  Two
Identical Analyzers, Always On, Reagent MxSystem
 Misplaced/misrouted samples  Right Siting
 Instrument downtime  Two Identical
Analyzers, Always On, Abbott Link
 Slide generation  As needed
77 Put science on your side. ©2011 Abbott
Company Confidential

78.  PROCESS
Eliminate Waste
- over-production
- waiting
- unnecessary transport
- over/incorrect processing
- defects
- unused employee creativity
Right Process - - > Right Results
Continuous Process Flow
No over-production (what he wants, when he wants,
in the amount he wants)
Level out workload
Right quality first time
Standardized task
Visual control – no problems hidden
Use reliable, tested technology

79. Start Small
Simplify
Streamline
Smoothing – flow, unevenness
Standardize
Skills
Staff

80. 2. Focus on Processes
Henry Ford Health Systems Labs
6 acute care hospitals
30 medical clinics
785 staff
11.1 million tests
Downtown Detroit Core Lab
6.5 million tests
80 ©2011 Abbott
Company Confidential

81.  PEOPLE
Continuous Feedback
 In-house Coaching
Lectures, brainstorming & discussion
Select “best” champions - supervisors
Morning Call
 External Dialog
- doctors & nurses
 K.I.S.S.
Keep it simply, simple

82. 1
• Harness Technology
• Focus on Processes
2
• Remember People
3
82 ©2011 Abbott
Chief (Clinical Effectiveness & Innovation)
Company Confidential

83. Thank you for your time
Put science on your side. tarchoon@gmail.com
 18th May, Hong Kong