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A vertical audit of a test for analysing concentrations of progesterone found that the reagents are stored in a refrigerator although the protocol stated they should be stored between 2 to 8°C. The temperature of the refrigerator was not monitored. A horizontal audit to measure the temperatures of refrigerators throughout the department showed none of them maintained temperatures betveen 2 to 8°C. The quality manager agreed with the departmental management team that the current storage of the reagents for this test was an unsafe practice and a critical non-compliance with CPA (Section 1.1) standards. (a) What are the implications of storing temperature critical reagents in this way? (b) What action is required to resolve this non-compliance? (c) How would you determine whether the problem has been rectified?

A vertical audit of a test for analysing concentrations of progesterone found that the reagents are stored in a refrigerator although the protocol stated they should be stored between 2 to 8°C. The temperature of the refrigerator was not monitored. A horizontal audit to measure the temperatures of refrigerators throughout the department showed none of them maintained temperatures betveen 2 to 8°C. The quality manager agreed with the departmental management team that the current storage of the reagents for this test was an unsafe practice and a critical non-compliance with CPA (Section 1.1) standards. (a) What are the implications of storing temperature critical reagents in this way? (b) What action is required to resolve this non-compliance? (c) How would you determine whether the problem has been rectified?

Human Anatomy & Physiology (11th Edition)
Human Anatomy & Physiology (11th Edition)
11th Edition
ISBN:9780134580999
Author:Elaine N. Marieb, Katja N. Hoehn
Publisher:Elaine N. Marieb, Katja N. Hoehn
Chapter1: The Human Body: An Orientation
Section: Chapter Questions
Problem 1RQ: The correct sequence of levels forming the structural hierarchy is A. (a) organ, organ system,...
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A vertical audit of a test for analysing concentrations of progesterone found that the reagents are stored in a refrigerator although the protocol stated they should be stored between 2 to 8°C. The temperature of the refrigerator was not monitored. A horizontal audit to measure the temperatures of refrigerators throughout the department showed none of them maintained temperatures between 2 to 8°C. The quality manager agreed with the departmental management team that the current storage of the reagents for this test was an unsafe practice and a critical non-compliance with CPA (Section 1.1) standards. (a) What are the implications of storing temperature critical reagents in this way? (b) What action is required to resolve this non-compliance? (c) How would you determine whether the problem has been rectified?
Transcribed Image Text:A vertical audit of a test for analysing concentrations of progesterone found that the reagents are stored in a refrigerator although the protocol stated they should be stored between 2 to 8°C. The temperature of the refrigerator was not monitored. A horizontal audit to measure the temperatures of refrigerators throughout the department showed none of them maintained temperatures between 2 to 8°C. The quality manager agreed with the departmental management team that the current storage of the reagents for this test was an unsafe practice and a critical non-compliance with CPA (Section 1.1) standards. (a) What are the implications of storing temperature critical reagents in this way? (b) What action is required to resolve this non-compliance? (c) How would you determine whether the problem has been rectified?
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