Checklist For Site Sop Required Elements: Johns Hopkins University Baltimore, MD USA

SMILE
Johns Hopkins University

Baltimore, MD USA
Author: Erin Gover Document Number: Pro71-08

Effective (or Post) Date: 7 August 2008
Review History Date of last review: 3 April 2020
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.
CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:

LIS Use and Validation
Element
CONTENT-SPECIFIC REQUIRED ELEMENTS
Present
LIS USE AND GENERAL PRACTICES
A manual for the system is available near workstation(s).
There is a written procedure that addresses laboratory-specific operation of LIS and
information on how to get help with issues.
LIS system has a time-stamped audit trail to track entries and changes.
Access to the system is restricted by user ID and password protection and is limited
only to authorized personnel.
Describe the system back-up (i.e., frequency, where files are copied, who’s
responsible, if copies are archived off site and how often, etc.) and file restoration
procedure.
Describe normal operating procedure when or if LIS system is not available.
Comments:
LIS VALIDATION
LIS validation will be performed initially, after any system change (by user, vendor, or
laboratory) and after data file restoration for normal data, critical results, revised
results and calculated results.
Acceptable criteria must be determined and documented for all result types.
a.) a.) All qualitative and quantitative automated or manual tests must be identical.
b.) b.) Calculated LIS data must be within +0.5 of the manually calculated result.
If any data is unacceptable, complete documentation, notify the laboratory director or
designee and do not use LIS to report patient results until the problem is resolved.
Retain and document the validation process (see #5 below).
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1. Normal Raw Data – Manual and Automated Tests

Randomly select normal raw data for all protocol analytes or method combinations
performed in the lab and gather raw data (analyzer print out or approved result report
for manual tests) and check for accuracy by comparing the following to the LIS report
printout:
a.) Patient Identification
a.)
b.) Specimen collection date and time
b.)
c.) Name of test
c.)
d.) Test result
d.)
e.) Unit of result
e.)
f.) Reference range
f.)
2. Critical Results
Randomly select high and low critical results data for all protocol analytes or method
combinations performed in the lab and gather raw data (analyzer print out or
approved result report for manual tests) and check for accuracy by comparing the
following to the LIS report printout:
a.) Patient Identification
a.)
b.) Specimen collection date and time
b.)
c.) Name of test
c.)
d.) Test result
d.)
e.) Unit of result
e.)
f.) Reference range
f.)
g.) Specific identifier or flag highlighting the critical value
g.)
3. Amended (Revised) Results
Create a “test patient” in the LIS for one test only (i.e., sodium). Amended results
validation is not required for all protocol analytes. The functionality can be verified
using one test analyte.
Enter test results. Once approved, amend the data at least twice and check the LIS
report printout for the following:
a.) Original and revised data are both present
a.)
b.) Multiple revisions of a single result appear in sequential order on the report
b.)
4. Calculation Verification (if applicable)
LIS calculated results (i.e., LDL calculated, Indirect Bilirubin, etc.) must be validated
initially, annually, and again after any system changes that could impact calculations
for protocol analytes.
Calculations based on patient parameters (sex, age, etc.) must be verified for
changes in each parameter.
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Obtain raw data (from analyzer printout or approved result report for manual test) and
manually calculate the correct result and compare the results to the LIS result report.
This should be repeated for all calculated protocol analytes.
5. Validation Documentation and Approval

Gather copies of all raw data and LIS reports used for the validation process to
include:
a.) a.) Normal results
b.) b.) Critical values
c.) c.) Amended reports
d.) d.) Calculation verification
The following personnel should approve and sign LIS validation information:
a.) a.) Laboratory Manager or designee
b.) b.) QA/QC Coordinator
c.) c.) Laboratory Director
LIS should not be used to report patient results until after the appropriate personnel
approve the validation data.
All validation data should be retained indefinitely or as directed otherwise by DAIDS.
Comments:
References:
 ICH E6 Good Clinical Practice: Consolidated Guidance (GCP)
 42 CFR 493: Laboratory Requirements
 Clinical Laboratory Improvement Amendments (CLIA) Self-Assessment Questionnaire
 College of American Pathologists (CAP), Laboratory General Checklist for Laboratory
Accreditation Program
 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies (GLP)
 21 CFR Part 11: Electronic Records
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SMILE

Johns Hopkins University

Author: Erin Gover Document Number: Pro71-08

CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:

520804236.doc Version#: 1.0

1. Normal Raw Data – Manual and Automated Tests

520804236.doc Version#: 1.0

5. Validation Documentation and Approval

520804236.doc Version#: 1.0

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