Focusing on Analytical and Post-Analytical Process

Ø Defining "Laboratory Error"

·        Laboratory errors as defined by Bonini et al, is "a diagnosis that is missed, wrong, or delayed, as detected by some subsequent definitive test or finding"

·        This has been further acknowledged and adopted by the ISO technical Report 22367, as "a defect occurring at any part of the laboratory cycle, from ordering tests to reporting, interpreting, and reacting to results"

Ø Approximate estimate of Lab errors

1.      1 in 330 to 1000 events

2.      1 in 900 to 2074 patients

3.      1 in 214 to 8316 test results

•       This is an approximate estimate

•       The incidence varies based on laboratory standard

Ø Modes to find Lab errors

•       Analyzing complaint from Patient and/or doctor

•       Internal audit or supervisory observation.

·        Pro-active feedback collection from patient/doctor

•       Consistently failing proficiency test

•       System and discipline to log events

Ø Approach towards Complaints and errors

•       To be treated as most important event needing personal addressal.

•       Serious consideration as an area of improvement.

•       This is an opportunity to: -

ü  Get involved

ü  Self audit

ü  Bring discipline/fear in staff

ü  Sincerity in work for staff.

ü  Keep staff on toes instead of getting over confident.

•       This is a chance to speak/impress a customer (patient/doctor)

•       Periodic review meetings on complaint and errors

Ø How does one react to a complaint?

•       On receipt of the complaint

•       On revert after analyzing it

•       How to ensure that complaints are recorded, escalated and closed to customer's satisfaction?

Ø What should be recorded?

•       Customer complaint, which may be -

ü  An error

ü  Perception

•       Internal error found, with situation where -

ü  The report was already submitted

ü  The report was not submitted

•       Non-compliance on various accounts -

ü  Non-delivery of service

ü  System lapses

•       Record service complaints also. E.g. -

ü  Delayed report.

ü  Improper/painful blood collection.

ü  Rude behavior of staff

ü  Unpleasant communication by customer care advisor.

ü  Hygiene and infrastructure complaint

Ø Classification of Lab errors

•       Latent errors

ü  These are the errors occurring due to -

ü  Organizational failures.

ü   Infrastructure and design

ü   Faulty policies from management.

•       Active errors

ü  The rest are active errors, which are of three types

ü  Pre-analytical errors

ü  Analytical errors

ü  Post analytical errors

Ø Latent errors

·        Chronic understaffing

·        Multi-tasking and improper job distribution amongst staff

·        Lack of instrument interface

·        Poor formatting of results

·        Overloading of analyzer and no back up

·        Poor laboratory layout leading to misplacement of specimen

·        Poor sample labelling policy

·        Policy, design and process pertaining to Test requisition form.

·        Poor communication between shifts and departments

·        Excessive focus of management on costs

·        Management's approach towards incident reporting

Ø Classifying Analytical Errors

•       Systematic errors - indicates poor accuracy

ü  Poor calibration

ü  Incorrect procedure

ü  Wrong standard

•       Random errors - indicates poor precision

ü  Pipetting error

ü  Transcription error

ü  Incorrect sample numbering

ü  Reader fluctuation.