Improving Laboratory Efficiency and Cost Effectiveness through Modification of Test Method
Raja Elina Raja Aziddin and Chan Kam Soon
Drug and Research Laboratory, Department of Pathology, Hospital Kuala Lumpur.
OP-11
Selection of Opportunities for Improvement
PROBLEM IDENTIFICATION �& PRIORITISATION
SMART Criteria
PROBLEMS IDENTIFIED | S | M | A | R | T | TOTAL |
Limited ATS test throughput | 4 | 5 | 5 | 5 | 4 | 23 |
Delay in Laboratory Information System (LIS) report printing | 4 | 4 | 2 | 2 | 2 | 14 |
Delay in drug report collection | 4 | 5 | 4 | 3 | 3 | 19 |
Sample rejection | 2 | 2 | 1 | 3 | 2 | 10 |
Incomplete test request | 3 | 3 | 2 | 3 | 1 | 12 |
23
REASONS FOR SELECTION
Criteria | Rationale |
| Limited ATS test throughput cause delay in ATS test turnaround time which can hamper court proceedings |
| ATS test throughput can be measured by the number of tests that can be done by the laboratory |
| Increasing the ATS test throughput will increase laboratory efficiency as the number of ATS test request is the most in number compared to other drug tests |
| Remedial measure to reduce the ATS specimen processing time and cost is feasible and there are no economical issues which may affect the success of this study. |
| This study and its remedial measure are manageable with the available resources and can be achieved in a timely manner |
MEASURABLE
APPROPRIATE
REMEDIAL
TIMELY
SERIOUSNESS
BACKGROUND
ATS ABUSE
Rising Concern Over Syabu Addiction Among Students In Kedah - Monday, 20 March 2017
NST
No remorse from teenagers nabbed over Keramat tahfiz school fire: Sources
ATS drug abuse - a growing problem in Malaysia
DRUG ABUSE DETECTION
ROLE OF THE LABORATORY
DRUG TEST PROVIDE KEY EVIDENCE
GIVE INFORMATION TO MAKE THE WORLD BETTER
INTRODUCTION
This increase in ATS abuse trend has resulted in a steady increase of ATS test requests.
Fig 1: Number of ATS samples and test requests received in Hospital Kuala Lumpur showing an increasing trend in the last four years
>65,000 SAMPLES / year
Fig 2: Hospital Kuala Lumpur workload showing the percentage of samples received for different drug tests
ATS
Police
LITERATURE REVIEW
Drug abuse is a global problem that knows no borders. It is a major health problem that impacts communities and take a tremendous toll on the society.
The emergence of new synthetic drugs in recent years has resulted in a change of trend in drug use.
Today traditional illicit substances like heroin are becoming less popular globally, more are turning to new designer drugs such as AMPHETAMINE TYPE STIMULANT (ATS) Drugs.
(World Drug Report: United Nations Office on Drugs and Crime - 2015)
PROBLEM STATEMENT
Monitoring of the ATS drug tests turnaround time showed there is a delay in ATS test result reporting to cater to the existing workload which may hamper court proceedings.
GENERAL OBJECTIVE
To Improve Laboratory Efficiency and Cost Effectiveness through Modification of Test Method
SPECIFIC OBJECTIVES
TO IMPROVE
LAB EFFICIENCY
AND
COST EFFECTIVENESS
No new intake
Lab deigned
in early 90s
Limited functioning
fumehood
Maintenance
downtime
30% staff
transfer yearly
Congestion
Manual
Limited trained
personnel
Expensive
Complex
Require
expertise
INADEQUATE WORK AREA
INSUFFICIENT EQUIPMENT
COMPLICATED SAMPLE PROCESSING
INSUFFICIENT MANPOWER
Overworked
instrument
No increase
in GC/MS
Since 2010
OPPORTUNITY FOR CHANGE
January 2015 :
Gas
Chromatography
Mass
Spectrometry
(GC/MS) systems
with higher
sensitivity to
replace obsolete
units
Key Measurement for Improvement
MODEL OF GOOD CARE
Sample received
NEGATIVE
POSITIVE
Run Confirmatory Test
Result
analysis
Screening Test
Report
HOSPITALS
Others agencies
14 DAYS
AADK
Sample Receiving
Sample checking at receiving counter
Preparing of screening
Screening on automated analyser
Specimen processing ( 1 )
Specimen processing ( 2 )
Extraction of sample
Concentration process
( DRYING STEP)
Concentrated sample
( DRYING STEP)
Sample in micro insert tube
( DRYING STEP)
Place into micro vial
Ready for GC/MS analysis
Comfirmatory GC/MS analysis
COMFIRMATORY TEST �WORK PROCESS
Add 20 µL internal standard
Add 0.5 ml buffer
Add 2.5 ml extraction solvent
Add 10 ml derivation reagents
Spin for 3 minutes
Transfer organic phase into drying tubes
Evaporate in dry bath 50ºC to
about 90 µL
Transfer the extract into micro vials with glass insert and cap
Existing ATS test work process
Pipette 2.0 ml urine samples
Ready for GC / MS analysis
Drying steps
COST BENEFIT ANALYSIS
BIL | ITEM | TOTAL COST |
1 |
| |
2 | | Tank X Month X Cost 8 X 12 Months X RM 250 = RM 24,000 |
3 | GS / MC filament | Years X Rm 600 = RM 7200 |
RM 0.95 X 65,000 (samples)
= RM 61,750
INDICATORS AND STANDARD
Standard: turnaround time < than 14 days in 90% of the ATS test requests received.
*Seksyen 117 ( 3 ) KAJ, pihak Majistret mempunyai kuasa bagi membenarkan satu perintah penahan reman dibuat ke atas suspek sehingga 14 hari.
( >14 days eligible as DNAA – Discharge Not Amounting Aquictal).
*KPI of Drug Lab Unit, Pathology Department
The number of ATS samples with less than 14 days test turnaround time | X 100 % |
Total number of ATS samples received |
Process of Gathering Information
METHODOLOGY
TYPE OF STUDY | Prospective | ||
SAMPLE SIZE | Cases that required ATS confirmatory test | ||
SAMPLING TECHNIQUE | Convenient | ||
LOCATION OF STUDY | Drug and Research Lab HKL | ||
PERIOD OF DATA COLLLECTION | Verification Study Jun - Aug 2015 | Validation Process Sept – Dec 2015 | Implementation of Remedial Measures Jan 2016 – Jan 2017 |
INCLUSION CRITERIA | Samples for ATS confirmatory test | ||
EXCLUSION CRITERIA | Samples not for ATS confirmatory test | ||
Urgent samples | |||
DEFINITIONS |
|
|
|
|
Analysis And Interpretation
DATA COLLECTION
Strategy for Change
REMEDIAL MEASURES
We established a Modification Of Confirmatory Test Method In Work Process which includes:
micro vials
REMEDIAL MEASURES
9
7
REMEDIAL MEASURES
Micro vials with glass insert and cap
Micro vials with barcode
200 ul
1000 ul
Effect of Change
METHOD VALIDATION
| Existing method | Modified method | |
Linearity | 0-10,000 mg/ml Coefficient of variation r²= 0.9999 | 0-10,000 mg/ml Coefficient of variation r²= 0.9999 | |
Sensitivity | LOD | 11-40 ng/mL | 20-30 ng/mL |
LOQ | 33-150 ng/mL | 70-90 ng/mL | |
Accuracy | ±20% | ±20% | |
Precision | <10% | <10% | |
Specificity | No interfering compounds detected at the respective compound retention times | No interfering compounds detected at the respective compound retention times | |
Stability | 1 month | 1 month | |
Table 1: Comparison of method validation data for six ATS analytes
RE-VALIDATION�SIX LEVEL CALIBRATION CURVE - ATS DRUGS
Calibrator Concentrations : 100 ng/ml , 250 ng/ml, 500 ng/ml/ 1000 ng/ml, 2000 ng/ml/ 5000 ng/ml
EQA
CAP
UNODC
METHOD CORRELATION
Fig 4: Scatter plot showing good correlation of Amphetamine results on existing and modified method
Fig 5: Scatter plot showing good correlation of Methamphetamine results on existing and modified method
Method correlation experiments compared the results of 27 samples that were analysed using existing and modified method
PROCESSING TIME
Add 20 µL internal standard
Add 0.5 ml buffer
Add 2.5 ml extraction solvent
Add 10 ml derivation reagents
Spin for 3 minutes
Transfer organic phase into drying tubes
Evaporate in dry bath 50ºC to
about 90 µL
Transfer the extract into micro vials with glass insert and cap
2.5 hrs
Pipette 2.0 ml urine samples
Ready for GC / MS analysis
Drying steps
~ 1 hr
(2.5 – 1)H = 1.5 HRS
ATS TEST THROUGHPUT
Table 2: Comparison of the time taken to process one batch of 78 samples using existing and modified ATS method.
| ATS throughput | Increment of Batches | |
Existing method | Modified method | ||
Number of batches and samples processed per day | 3 batches (234 samples) | 6 batches (468 samples) | 50% |
ATS TEST THROUGHPUT
The modified method reduced sample processing time by 50%, resulting in a doubling of ATS test throughput per day.
Fig 6: Comparison of number of samples processed per day with existing and modified method
50%
TURNAROUND TIME
Fig 7: Percentages of ATS specimens with turnaround time of less than 14 days
COST COMPARISON
Table 3: Cost savings calculated based on the consumables used for the total ATS workload in 2016
COST COMPARISON
Cost saving of 46.6% which amounted to RM46,350 per year.
Fig 8: Cost reduction post modification of test method.
RM 46,350 / YEAR
ABNA
Number of ATS specimens with turnaround time of less than 14 days
Lesson Learnt �And �The Next Step
LESSONS LEARNT
LESSONS LEARNT
3) Simple modifications has resulted in saving of :
a) Time
b) Cost
c) Reducing errors :
- by using micro vial with barcode
d) Human Resources :
- physical activity such as tube transfers,
washing of micro vials, frequency of
changing gas tanks and instrument
filament.
THE NEXT STEP
Phase 1
1) Information on the use of new modified ATS test method was announced during National Pathology Meeting
UPDATES ON DRUG ABUSE TESTING SERVICE IN HKL�Mesyuarat Perkhidmatan Patologi KKM
Bil. 2/2017 - 14 Ogos 2017
THE NEXT STEP
Phase 1
2) Conduct training / seminar to other ATS testing centres on the use of the modified method
STAFF TRAINING
SEMINAR
THE NEXT STEP
Phase 1
3) Short attachment in HKL on the use of the modified ATS test method in HKL for representative from other centres
Letter : Request of Attachment
THE NEXT STEP
Phase 2
HKL pioneered the existing and current modified ATS test method.
Continuous quality improvement activities is important to ensure excellent service provision.
CONCLUSION