Dynamic List Information
Dynamic List Data
Title
Onsite/Offsite Follow-up/Revisit Survey Guidance
Memo #
Admin Info: 24-09-CLIA
Posting Date
2023-12-18
Fiscal Year
2024
Summary
Memorandum Summary
• Offsite follow-up/revisit surveys are authorized for the following:
o When no condition-level non-compliance is cited within 12 months of the original survey and for mandatory condition-level deficiencies related to proficiency testing (PT) enrollment, 42 CFR § 493.801, unsuccessful participation in PT, 42 CFR § 493.803, and personnel qualifications in subpart M – Personnel for Nonwaived Testing, 42 CFR §493.1351 through 42 CFR §493.1495.
• Onsite follow-up/revisit surveys are authorized for the following:
o To verify compliance or confirm continuing serious non-compliance.
o Prior to the imposition of principal sanctions when the laboratory does not provide an acceptable credible allegation of compliance (AoC) and for condition-level non-compliance related to personnel responsibilities in subpart M – Personnel for Nonwaived Testing, 42 CFR §493.1351 through 42 CFR §493.1495.
• Offsite follow-up/revisit surveys are authorized for the following:
o When no condition-level non-compliance is cited within 12 months of the original survey and for mandatory condition-level deficiencies related to proficiency testing (PT) enrollment, 42 CFR § 493.801, unsuccessful participation in PT, 42 CFR § 493.803, and personnel qualifications in subpart M – Personnel for Nonwaived Testing, 42 CFR §493.1351 through 42 CFR §493.1495.
• Onsite follow-up/revisit surveys are authorized for the following:
o To verify compliance or confirm continuing serious non-compliance.
o Prior to the imposition of principal sanctions when the laboratory does not provide an acceptable credible allegation of compliance (AoC) and for condition-level non-compliance related to personnel responsibilities in subpart M – Personnel for Nonwaived Testing, 42 CFR §493.1351 through 42 CFR §493.1495.