Regulatory and Compliance Management
Who regulates what
CLIA '88 sets the federal minimum for laboratory testing through CMS, covering registration, certificate type (waived, moderate, high complexity), personnel qualifications, quality control, proficiency testing, and inspection. CAP, The Joint Commission, and state agencies may impose stricter requirements; state licensure can exceed federal rules, and the stricter standard applies. FDA governs devices and in vitro diagnostics; OSHA governs worker safety, including the Bloodborne Pathogens Standard with its exposure control plan, hepatitis B vaccination offer, and post-exposure evaluation; HIPAA governs protected health information under privacy and security rules.
Testing requirements
Laboratories must follow manufacturers' instructions, perform the specified QC (with defined exceptions for certain specialized and qualitative tests), enroll in an approved proficiency testing program for regulated analytes, and evaluate PT results - referrals of PT specimens to another laboratory are prohibited. Records, including QC and proficiency testing documentation, are generally retained at least two years, with longer retention for some specialty areas and under state or accreditor rules.
Compliance program elements
A compliance program includes written policies, a compliance officer and committee, training, lines of communication, internal monitoring and auditing, and enforcement with corrective action. Fraud-and-abuse statutes (federal Anti-Kickback Statute, Stark physician self-referral law) prohibit remuneration for referrals and require careful structuring of outreach arrangements with referring physicians.
Trap to expect
Questions often offer "CLIA accreditation" as an option; CLIA is a certification program, while CAP and The Joint Commission grant accreditation deemed to meet CLIA. Another trap: assuming a waived test needs no quality oversight - waived testing still requires following manufacturer instructions and good practice.