Survey-ready is a weekly habit, not a week in April.
OIG exclusion rules, documentation completeness, and exportable evidence. Global Hands supports the systems that test. It does not bill federal programs or hold a CLIA number.
LEIE is healthcare-specific. SAM is the complement. Neither is optional.
The rule
42 CFR 1001.1901: no payment under Medicare, Medicaid, or other federal healthcare programs for items or services furnished, ordered, or prescribed by an excluded individual or entity.
Who to screen
Employees, contractors, locums, and certain vendors. A PHL that only 'does public health' still touches federal program funds more often than the org chart admits.
How often
LEIE updates monthly. SAM is complementary, not a substitute. A one-time hire check is not a program.
What to keep
Who was screened, which list, which date, who reviewed an alert, and what was done. That log is the survey artifact.
Primary list: OIG List of Excluded Individuals and Entities. Complementary: GSA System for Award Management.
What a director should be able to export before the surveyor sits down.
Personnel and competency
- Current CLIA personnel files for high-complexity testing
- Competency assessments tied to the tests each person actually performs
- Exclusion screening log (LEIE + SAM) with review signatures
Methods and validation
- Validation or verification packets for every live assay, including LDTs
- SOP version history with effective dates, not just the current PDF
- Proficiency testing enrollment and scored results
Reporting and integrity
- ELR companion mapping (LOINC / SNOMED) for reportable tests
- Documentation of what the laboratory does not do: no patient-level AI diagnosis, no unsupervised release
- Audit trail export covering accession, result, verify, and transmit