Pathology Lab Assignment: Correlation, Validation, New Tests, Errors

This report focuses on the critical concepts of correlation and validation within the context of a pathology laboratory. It begins by defining validation as the process of ensuring an assay's fitness for its intended purpose, emphasizing its importance in confirming the accuracy and reliability of test results in relation to a patient's condition, its diagnostic value, and cost-effectiveness. The report then delves into the procedure for implementing new tests and reagent batches, outlining the planning, implementation, and control phases. It also addresses the different types of errors that can occur in a medical laboratory, including preanalytical, analytical, and postanalytical errors. The report provides insights into policies and procedures designed to mitigate these errors, such as patient identification protocols, quality control measures, staff training, and data validation. Finally, the report emphasizes the importance of staff competency and in-service programs to ensure the accuracy and reliability of laboratory results, which are crucial for accurate diagnosis and patient care.

PATHOLOGY LAB
Name
Institution

What is meant by correlation and validation of results and investigations in medical
laboratory?
Validation describes the process of determining an assay’s fitness that has been
developed, optimized a well as standardized properly for a particular intended purpose. All lab
assays must be validated for species whereby they shall be utilized. It entails estimates of
analytical as well as diagnostic performance features of the given test. 1 The validation in
medical is the process of confirming whether a given test fulfils the following four criteria: The
test results is validated whether it reflects the reality in the body of the patient. The test result
also is validated whether it has a significant relationship with the underlying disease. 2 The test
result is also validated whether it provides additional information which is not available already.
It is also validated whether the test is cost-effective ad whether the cost if the test is justified by
its usefulness. Correlation means the significant relationship between the test results with the
disease in question. 3
Discuss the procedure for new tests and batches of reagents required for diagnosis
Planning process
Involves allocating duty to a person who undertakes the process of validation and would
be responsible for the final result and making decision. The requirement of the method to be used
must be defined prior to testing like limits, range of work, desirable quantity and accuracy. The
document for description ought to be clear and detailed such that any trained lab technician use
it.
Implementation
This involves the application of the values of the limits set in the requirement stage like
accuracy, quantification and precision. The parameters are liable to change depending on the

approach used by the technician. The activities and the recorded outcomes are implemented
according to date, operative and the final results.
Control
Involves verifying if the all the requirements defined in the planning process have been
complied with by the operator. After the implementation of all the undertakings, the
requirements are checked and scrutinized to validate if they meet the standards. For example
using control measures from time to time and check limits of the line of regression. Then include
such regressions if any in the process and hence make final outcome from the test. 2 The
procedure is then declared if it was rightly followed to the end. Finally, an official declaration is
made concerning the suitability of the method used for the purpose for which it was intended.
Errors, policy and procedures to avoid them
Errors of preanalysis
The error comes from the physician at the analytic stage. It occurs in the identification of
the patient, assortment, movement and analysis preparation. These errors occur either within or
without the laboratory for example misidentifying the patient. 4 There is a policy that ensures that
a patient is identified either by use of name or date of birth or using some codes on the
wristband. Also ensuring integrity of the specimen and the patient. Ensuring communication
among the patient attendants in the assessment of patients.
Analytical errors
They happen during testing due to machine failures, mixing of samples and interference.
Use of automation to follow up, discover and record errors during testing. The equipment to be
used should be tested to ascertain if they functional. Quality of management through safety of

patient in the laboratory ensuring quality key indicators in the laboratory. Also frequent staff
training can help in overcoming the errors.
Post analytical errors
These errors occur after the actual testing due to poor recording, reporting, poor entry of
data and poor interpretation and validation of data. Evaluating the competency of the staff as
well as carrying out in-service programs for the staff.

Reference
1. Annals of Laboratory Medicine.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3255486/
2. Aziz N, Zhao Q, Bry L, Driscoll DK, Funke B, Gibson JS, Grody WW, Hegde MR,
Hoeltge GA, Leonard DG, Merker JD. College of American Pathologists' laboratory
standards for next-generation sequencing clinical tests. Archives of Pathology and
Laboratory Medicine. 2014 Aug 25; 139(4):481-93.
3. Hammerling JA. A review of medical errors in laboratory diagnostics and where we are
today. Laboratory Medicine. 2015 Sep 18; 43(2):41-4.
4. Rehm HL, Bale SJ, Bayrak-Toydemir P, Berg JS, Brown KK, Deignan JL, Friez MJ,
Funke BH, Hegde MR, Lyon E, Working Group of the American College of Medical
Genetics. ACMG clinical laboratory standards for next-generation sequencing. Genetics
in medicine: official journal of the American College of Medical Genetics. 2013 Sep;
15(9):733.