Post Analytical Best Practices

Labs For Life PPT Series

Post Analytical Error Per cent: CLSI
 Post Analytical Errors: Reports
Within laboratory

• Validation of erroneous data

• Incomplete/inadequate/ambiguous reports
• Excessive turn-around-time
• Improper data entry and manual transcription
error
• Failure/delay in reporting critical values
• Incorrect/Inadequate inter­pretation
 Post Analytical Errors: Reports
Outside laboratory

• Inappropriate/inadequate follow-up plan

• Delayed/missed reaction to laboratory
reporting
• Failure to or­der appropriate investigations
 Post Analytical Errors: Samples

• Improper retention of samples

• Improper discarding of samples
• Improper Bio Medical Waste Management
Post Examination Phase, ISO 15189
 Review of Results
VALIDATION ITSELF IMPLIES VALUE ADDITION!

Result Review Report

 Policy and Documented Procedures

• Review of results by authorized personnel.

• Validation by a designated authorized
signatory.
• These authorized personnel should be
designated based on technical competency
and experience.
(NABL-112 gives a reference to MCI regulations as to
who should be an authorized signatory in a laboratory)
 Factors to note during validation
Key Factors:
– Internal Quality Control results for the parameters
tested
– Appropriate Clinical Information
– Previous Examination (Test) Results
Also be mindful of:
– Biological Reference Values
– Critical Values
 Waived Tests
• Some POCT are waived with regard to
validation by authorized signatories of the lab.
• Such decisions maybe made as per the
facility’s guidelines.
• However, CLIA guidelines are available to
decide which tests can be waived.
https://www.cms.gov/Regulations
Post Examination Phase, ISO 15189
 Sample Management
• Retention
• Storage Indexing and monitoring
• Storage validation
• Disposal of samples
 Sample Retention
• For repeat examinations and additional
examinations
• Up to a specified period
• Retention period will vary from analyte to
analyte based on sample stability for the analyte
– Institutional, regional and national guidelines
– Regulatory & accreditation body guidelines such as
NABL 112
– Kit manufacturer’s instructions (kit inserts).
Additional benefits of Sample Retention: CLSI

• Validate/verify new method, or

• Introduce new lot or a new batch diagnostic
kits, or
• Verify change in calibration material, or
• Training purposes, or
• Assess competency of staff
 Sample Storage Indexing

• Sample storage fridge

should be separate from
the reagent storage fridge
• A system of identifying
the date of collection
• The temperature
monitoring across all the
racks and the door
• A calibrated thermometer
is to be used for this
 Storage Validation
• A sample analyzed at the end of the storage
period should yield similar or acceptable results
as the original.
• For quantitative tests, this can be done by
repeat examination at the end of the specified
storage period and finding per cent difference
• Laboratories should have mechanisms to
validate semi-quantitative and qualitative tests
also.
 Disposal of Bio Medical Waste
• Follow national, state and local guidelines for
BMW management and disposal.
• Refer to BMW rules 2016 for details
• Please refer to the BMW management videos
and webinars on this site for more details
 NABL 112
Treatment outside laboratory premises:
• A documented contract with a licensed BMW
Management Contractor
• Follow the protocols laid by the contractor
regarding segregation of waste.
• Colored posters to be displayed at different sites
of BMW generation for ready reference of the
staff.
• Evacuated tubes to be treated as per the
contractor’s requirement.
 NABL 112
Treatment inside laboratory
• Infectious microbiology waste – All infectious
waste shall be autoclaved before disposal.
• The laboratory should have a separate autoclave
for waste treatment.
• Other samples shall be treated with 1% fresh
hypochlorite solution for 30 mins. This can then
be poured down the drain in running water.
• An effluent treatment plant may be placed as per
local requirements.
Post Examination Phase, ISO 15189
 Reporting of Results
General Requirements for Laboratory Reports (5.8.1)

• Should have Report Formats fir for the purpose

• Should be in accordance with the SOP
• Should be Checked for Transcriptional Errors
• Should give Interpretative information
• Should accord importance to immediate notification if
required
 Reporting of Results
General Requirements for Laboratory Reports (5.8.1)

• Report Format
• In accordance with the SOP
• Check for Transcriptional Errors
• Interpretation
• Notification
 Reporting of Results
General Requirements for Laboratory Reports (5.8.1)

• Report Format
• In accordance with the SOP
• Check for Transcriptional Errors
• Interpretation
• Notification
 Reporting of Results
General Requirements for Laboratory Reports (5.8.1)

Reports must be meaningful and useful. For this a few steps

must be adopted
• Proper Report Format
• Clarity, unambiguity, conformance with the SOP
• Checked for Transcriptional Errors
• With Interpretation
• Notification
 Report Format
The test report is the final product of the laboratory!
Blank Lab Stationery
• Test Request and Report Form Lab Information System Required
• Preformatted Possibility to remap data if method/BRI
• Manual Entry change
• Transcription errors high chance Transcription errors minimised if equipment
are interfaced
• Cost effective
Cost high
• Has to change printed stationery if
method/ BRI change
 In accordance with the SOP

The results of each

examination should be
reported accurately, clearly,
unambiguously and in
accordance with any specific
instructions in the test
procedures
 Check for Transcriptional Errors

Tally equipment printouts,

workbooks, datasheets with
reports
Interpretation
Warranted for all tests as
per scope
For all screening tests it
should be specified so
 Notification
Instilling confidence in of laboratory’s ownership of the process

If there is a delay in
reporting
If there is need for fresh
samples
More clinical information
needed
Others
 Report Attributes
• Comments on sample
quality
• Comments regarding
sample rejection
• Critical Reports
 Comments on sample quality
• Compromised
samples(e.g.
hemolytic/lipemic serum
sample).
• This implies that the test
has been done regardless
of the compromised
sample integrity.
• E.g. a hemorrhagic CSF tap, samples from
newborns and other precious samples that
cannot be replaced easily.
 Comments regarding sample rejection
• Where samples are
rejected and needs
replacements
• Reason for rejection
 Critical results
• Those values high or
low that can impact
patient survival if not
informed immediately
• Lab should have a
procedure for this
• Proper documentation
needed.
 Report Content (5.8.3)
1. A clear identification 4. Patient identification
of the examinations (unique identification
2. The identification of number) and patient
the laboratory that location
issued the report (ward/address) on
3. Identification of all each page.
examinations that 5. Name of other unique
have been performed identifier of the
by referral laboratory requester and the
requester’s contact
details
 Report Content (5.8.3)
6. Date and time of primary 10. Biological reference
sample collection intervals (BRI), clinical
decision values
7. Type of primary sample
11. Other comments such as
(serum/whole
cautionary or explanatory
blood/plasma/urine/stoo notes
l etc.). 12. Identification of the
8. Measurement procedure person(s) reviewing the
9. Examination results results and authorizing the
reported in SI units, or release of the report
other applicable units 13. Page number to total
number of pages
Common problems in reporting
Complaints and Resolution of Complaints
 Release of Results
Documented procedures (QSPs) for the release of
examination results
• Password/counterfoil/acknowledgement receipt
system for patients and attendants at
reception/report dispatch counter.
• Release through LIS e.g. on websites/mobile
SMS/emails.
• Designated hospital staff delivering reports by
one to one interaction
 Interim (preliminary) and final reports
• Critical reports not authenticated as per SOP e.g.
Positive finding in Gram stain of blood/ CSF culture
• NABL 112 on interim reporting
– Daily Internal Quality Control (IQC) shows no violation of the
documented policy and procedure.
– The technical personnel (e.g. technician) posted during this
period should be well trained and of proven competence to
apply IQC rules.
– The regular authorized signatory should go through the
records on the next working day and issue a final report
– Maintain records.
 Revised reports
In the event of wrong reports that needed correction

• The revised report is clearly identified as a revision and

includes reference to the dates and patients identify in the
original report
• The user is made aware of the revision
• The revised record shows the time and date of the change
and the name of the person responsible for the change
• The original report entries remain in the record when
revisions are made
• Appropriate review of such incidents may be done to
prevent recurrence
 Urgent reports
• On request of clinician or user
• A documented procedure should be available
with instructions for
– special labeling of request forms and samples,
– mechanisms of transfer
– rapid processing mode to be used
– reporting criteria.
 Verbal release of reports
• The lab should have procedures for ensuring that results
distributed by telephones or electronic means reach only
authorized recipients.
• All such communication should be documented with date,
time and signature of the person communicating the result.
• There should also be a mechanism available for verifying the
authenticity of the caller. Results provided orally should be
followed by a written report.
• It is the prerogative of the laboratory to determine the
protocols.
• All such communications should be documented.
 A format for verbal reporting

Name of Lab/ department:__________________________________

Month and Year:___________________________________________

Date Time ID Name Ward/ICU Parameter Reported to Reported by Signature

reported

                 
 Report Turnaround time (TAT)
A Key Performance Indicator
• Ideally it is the interval from the time physician/user
ordered the test to the time the results reach the patient
record.
• Practically it is the time taken starting from sample
collection or sample receipt by laboratory to reporting of
results.
• The laboratory needs defined and documented procedures
for notifying the requester if tests which could compromise
patient care are delayed.
• In many walk-in laboratories or reports for OPD patients
when LIS is available, the report are released is only when
the reports are collected. In such case the time of
authentication may be considered as the time of release
Automated selection and Reporting of
Results
• The process where a computerized system
does the verification of reports instead of it
being a manual process
• On test results that may not require any
further interpretations, recommendations or
further review by authorized personnel
– Reducing manpower requirements
– Increasing service quality
– Simplifying processes
– Decreasing the report release turnaround time
Laboratory Information Management
System: Manual and Electronic
Important
elements of LIS
Record keeping
and retrieval

Effective
Sample tracking
communication

Confidentiality/Data Organizing
protection documents

Timeliness
/critical alert Accuracy
• Thanks