Federal Patient Safety Regulations Flashcards
1
Q
Roles of:
Patient Safety Organizations (PSO)
(2)
A
- Collection and analysis of data voluntarily reported by healthcare providers to help improve patient safety and healthcare quality.
- Provide feedback to healthcare providers, aimed at promoting learning and preventing future patient safety events.
2
Q
PSO’s are regulated by what federal agency?
A
The Department of Health and Human Services (DHS)
Agency for Healthcare Research and Quality (AHRQ)
3
Q
What federal law applies to PSO’s?
A
The Patient Safety and Quality Improvement Act (PSQIA) of 2005
“The Patient Safety Act”
42 USC § 299b-21 to § 299b-26
4
Q
What law did the PSQIA amend?
A
Title IX of the Public Health Services Act (PHSA)
5
Q
What federal regulations apply to PSO’s?
A
The Patient Safety and Quality Improvement Rule
“The Patient Safety Rule”
42 CFR Part 3
6
Q
What other guidance about PSO’s is provided by the DHS?
(2)
A
- “Patient Safety and Quality Improvement Act of 2005 – HHS Guidance Regarding Patient Safety Work Product and Providers’ External Obligations”
- Federal Register, Vol. 81, No. 100, 05/24/16, Rules and Regs, pp. 32655-32660.
- “HHS Guidance Regarding Patient Safety Organizations’ Reporting Obligations to the FDA”
7
Q
What is the role of the AHRQ?
A
Under the authority of the PSQIA, the AHRQ, a division of the DHS, certifies and lists PSO’s.
