11-module8-laboratory-testing
11-module8-laboratory-testing
MODULE 8
Laboratory
Testing
Performance Outcome
With satisfactory participation in the training and successful implementation of laboratory
improvement projects, a participant’s laboratory should achieve the following outcome:
All laboratory tests are performed promptly and accurately
Test results are validated and recorded before release
1. Monitor testing to ensure SOP’s are followed and tests are performed and
reported properly and promptly
2. Cross-check test reports against test request to ensure completion of all
tests
3. Review test records and findings promptly to ensure accuracy and timely
release of test results
4. Validate assigned tests and specific abnormal results
TABLE OF CONTENTS
This activity supports the following laboratory management tasks and SLIPTA checklist items
Management Tasks 6.4 Validate new equipment, reagents, and supplies
7.3 Enforce good specimen handling and processing practices
8.4 Validate assigned tests and specific abnormal results
Checklist Items 1.2 Laboratory Quality Manual Is there a current laboratory quality manual,
composed of the quality management system’s policies and has the manual
content been communicated to, understood and implemented by all staff?
1.5 Laboratory Policies and Standard Operating Procedures Are policies and/or
standard operating procedures (SOPs) for laboratory functions, technical and
managerial procedures current, available and approved by authorized
personnel? (Purchasing and Inventory Control; Pre-examination Processes;
Validation and Verification of examination procedures / Equipment; Quality
Control and Quality Assurance)
6.1 Internal Audits Are internal audits conducted at intervals as defined in the
quality manual and do these audits address areas important to patient care?
7.10 Product Expiration Are all reagents/test kits in use (and in stock) currently
within the manufacturer-assigned expiration or within stability?
8.1 Information for patients and users Are guidelines for patient identification,
specimen collection (including client safety), labelling, and transport readily
available to persons responsible for primary sample collection?
8.2 Does the laboratory adequately collect information needed for examination
performance?
8.3 Are adequate sample receiving procedures in place?
8.4 Pre-examination Handling, Preparation and Storage Where testing does not
occur immediately upon arrival in the laboratory, are specimens stored
appropriately prior to testing?
8.7 Documentation of Examination Procedures Are examination procedures
documented in a language commonly understood by all staff and available in
appropriate locations?
8.8 Reagents Acceptance Testing Is each new reagent preparation, new lot
number, new shipment of reagents or consumables verified before use and
documented?
8.9 Quality Control Is internal quality control performed, documented, and
verified for all tests/procedures before releasing patient results?
8.12 Are environmental conditions checked and reviewed accurately?
9.1 Test Result Reporting System Are test results legible, technically verified by
an authorized person, and confirmed against patient identity?
9.2 Testing Personnel Are testing personnel identified on the result report or
other records (manual or electronic)?
ACTIVITY AT-A-GLANCE
Step Time Resources Key Points
PROCESS
Preparation
Procure 6 sheets of flipchart paper and 6 markers.
Label at the top of 2 sheets with the heading, “Pre-analytical.” Repeat this
labeling for “Analytical” and “Post Analytical” so that you create 2 sets of 3
sheets each with one of the phases labeled at the top.
Project Slides 8.5 to 8.6 to introduce the activity and the total testing
process. Review the 3 phases so that each participant understands what
activities occur within each phase. If the ‘Process Table’ (from the Process
Mapping activity) is still visible in the classroom, point out the 3 phases and
their associated steps.
Emphasize that a problem or error in any of the three phases can invalidate the
results of the whole testing process. Stress that wrong laboratory results will
negatively impact the quality of the patient’s care and treatment.
Explain the importance of identifying all the potential sources of errors or
problems that can invalidate the patient’s results. By recognizing these
potential pitfalls, a validation checklist can be created.
Provide an example of a potential error and a checklist item for each phase.
See the table for suggested examples.
The aim of quality assessment (QA) is to create and follow policies and
procedures so that the most accurate and reliable laboratory results are
provided and to minimize errors throughout all phases of the total testing
process.
Quality Control (QC) is a component of QA. A QC system monitors and detects
changes in the analytical performance of the test system. QC is used to validate
the analytical phase of patient testing.
QA activities must go beyond the boundaries of the laboratory to monitor all
aspects of laboratory performance.
The quality manual contains the laboratory’s overall quality policy, the quality
objectives, and the policies, processes, and procedures for each quality system
essentials (QSE’s). Overall, the laboratory requires two types of manuals, one
containing all the technical procedures necessary for the three phases of testing,
and a quality manual. The quality manual contains all non-technical procedures
that are integral for managing a quality laboratory. Examples of non-technical
areas include: training staff and assessing competency, defining document and
record retention schedules, investigating occurrences, and defining safety
practices, laboratory restrictions, and the use of personal protective equipment
(PPE).
Pre-analytical
Patient identification
Correct specimen labeling
Proper patient preparation
Proper sample presentation
Requisition/order matches specimen
Requisition has accurate contact (ordering party information)
Specimen in acceptable condition
Specimen transported appropriately
Log book entry matches specimen
Any abbreviations are confirmed
Person collecting the samples is identified
Date and time of collection is indicated
Analytical
Results make sense clinically
Results are within the linearity of the analyzer’s range
If diluted, final results are calculated correctly with the correct dilution factor
There were no flags on the analyzer’s results that need investigation
QC associated with the result run was acceptable
Reagents and test kits used are within expiry date
Panic (critical) values are confirmed
Confirmatory testing or established testing algorithms are completed
Previous patient results are available to assist with interpretation of current
sample’s result
Post Analytical
Each test ordered has an appropriate result including test and result match
Proper concentration units for result has been used
Decimal place is correct if result has decimals
Person performing the test is identified
Result release is dated and timed
All results and documentation are legible
Immediate notification and documentation of a Panic (critical) Value.
Submission of results and verification of the recipient’s accurate receipt of
results using a read-back-of-results mechanism.
Report interpretative information, which assists clinician with interpretation of
test result (information is not misleading, inadequate or contradictory)
This activity supports the following laboratory management tasks and SLIPTA checklist items
Management Tasks 8.1 Monitor testing to ensure SOPs are followed and tests are performed and
reported properly and promptly
8.2 Cross-check test reports against test request to ensure completion of all tests
8.3 Review test records and findings promptly to ensure accuracy and timely
release of test results
8.4 Validate assigned tests and specific abnormal results
9.1 Aggregate and report all test findings for each patient
Checklist Items 1.5 Laboratory Policies and Standard Operating Procedures Are policies and/or
standard operating procedures (SOPs) for laboratory functions, technical and
managerial procedures current, available and approved by authorized
personnel? (Identification and Control of Nonconformities; Authorization;
Reporting and Release of Results)
9.1 Test Result Reporting System Are test results legible, technically verified by
an authorized person, and confirmed against patient identity?
9.2 Testing Personnel Are testing personnel identified on the result report or
other records (manual or electronic)?
9.3 Report Content
9.4 Analytic System/Method Tracing When more than one instrument is in use for
the same test, are test results traceable to the equipment used for testing?
9.8 Test Result Are test results validated, interpreted and released by
appropriately-authorized personnel?
10.3 Is corrective action performed and documented for non-conforming work?
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-10
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-11
ACTIVITY AT-A-GLANCE
Step Time Resources Key Points
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-12
PROCESS
Preparation
Verify the printing quality is sufficient for Worksheet 1: Laboratory Report and
Worksheet 2: Report for Review in the participant’s manual. If printing quality
is insufficient or English is not used in the report, then procure blank in-country
result reports. Add entries (both errors and omissions) to create Worksheet 1.
Create an acceptable report to use for Worksheet 2. If the approved report
document is missing important information (i.e. reference ranges or units),
consider facilitating a discussion regarding essential report components and the
necessary steps to revise an approved document. Link this to the activity, Why
Was The Outdated Version Used?.
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-13
Project Slide 8.11 and refer participants to Handout: Errors Noted. Ensure
every error or omission was discussed. Refer to Tool for a list of errors and
omissions.
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-14
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-15
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-16
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-17
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-18
Cross-Checking Guidelines
Items to be verified prior to release of test results
Completeness Result Information
Each test has a corresponding result Legible
Patient information Proper placement of decimals
Clinical information Uniform result alignment with regards to decimal
Provider information placement
Specimen information Format of results corresponds with SOP
Collection information Proper units and significant places
Initials of staff member who performed each test Abbreviations used from approved list
indicated Within instrument linearity
Date and time of report No associated instrument codes with regard to accuracy
Result information identical with log book Result corresponds with correct test
Critical (Panic Values) Diluted results multiplied with correct dilution factor
Result verified and verification documented No consistent pattern or trend exhibited between
Documentation of result notification patients for a specific analyte during cross-checking
unless patient grouping under review is from the same
o On result report diagnosis/population pool (i.e. Newborn hemoglobin
o In log book and hematocrit)
Testing Priority Appropriateness
STAT request’s communicated and documented Test relevant to patient’s age and gender
Delays communicated and documented Result information makes clinical sense
Specimen Rejection o Electrolytes
o BUN/Creatinine
Reason for specimen rejection documented
o Macroscopic with microscopic
Clinician and / or patient notified and this notification
is documented o Instrument with smear
o RBC Indices, RBC count, Hemoglobin and
Hematocrit all show agreement
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-19
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?
TRAINER’S GUIDE (2015) 8-20
SLMTA Module 8: Laboratory Testing Activity: Is the Test Report Ready to Be Released?