CPPS Patient Safety Certification
Questions And Answers With Correct
Solutions 100%
The FDA has specific classifications for recalls - CORRECT ANSWES -- 1. Recall is
required if a product may cause serious adverse health consequences or death [FDA,
Title 21, Part 7, Section 3 (m)(1)].
2. Recall is required if a product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health consequences
is remote [FDA, Title 21, Part 7, Section 3 (m)(2)].
3. Recall is required if a product associated with a situation in which use of or exposure
to a product is not likely to cause adverse health consequences [FDA, Title 21, Part 7,
Section 3 (m)(3)].
advance health - CORRECT ANSWES -- One important route to restoring trust is
through a commitment to transparency by all health care systems. Organizations and
clinicians that act as though they have nothing to hide become more trustworthy. The
health care system should seek to earn renewed trust not by hiding its defects, but by
revealing them, along with making a relentless commitment to improve. The transition to
openness is a difficult one for our often-beleaguered health care organizations, but it is
a journey worth making. In the longer run, access to information can inspire trust among
patients and caregivers that the system is working effectively to
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a screen - CORRECT ANSWES -- Although trigger tools are neither perfectly sensitive
nor specific, they have reasonably good interrater reliability and often identify cases of
medical errors that incident reporting or administrative data-based systems miss. Since
many triggers do not represent errors or even true harm, they are best used as which of
the following?
Quality System Regulations - CORRECT ANSWES -- One of the goals of the FDA is to
protect the health of the public by assuring that the practice of reprocessing and reusing
single-use devices (SUDs) is safe and effective and based on good science. The FDA
has designed an approach that applies existing regulations for original equipment
manufacturers (OEMs) to third parties and hospitals to minimize risks associated with
reprocessed SUDs. The public expects and the law requires all medical devices to be
safe, effective, and manufactured in accordance with which of the following?
