Key facts and official sources
Default QC is defined in 42 CFR 493.1256(d), which allows an equivalent procedure if CMS approves it in SOM Appendix C.
IQCP guidance, including Table 1 (Eligibility for IQCP), is in SOM Appendix C.
CMS fully implemented IQCP on January 1, 2016, replacing the earlier "equivalent quality control" options.
When does IQCP make sense?
IQCP fits test systems with built-in or electronic controls, unit-use cartridges, or other designs where running external liquid controls every day adds cost without adding much error detection. For an analyzer that already runs two levels daily, default QC is usually simpler.
What goes in an IQCP risk assessment?
Identify possible errors across the pre-analytic, analytic and post-analytic phases for five components:
Specimen: collection, labeling, transport and acceptability
Test system: the instrument and its built-in controls, calibration and maintenance
Reagents: storage, shipping, lot changes and expiration
Environment: temperature, humidity, power and space
Testing personnel: training, competency and staffing
Base the assessment on your lab's own QC, PT, complaint, error and maintenance history, not only the manufacturer's claims.
What goes in the QC plan?
The QC plan sets out the controls for each risk you identified, including the type and frequency of QC. It must:
meet or exceed the manufacturer's instructions
be specific to the test, location and setting
be approved and signed by the laboratory director before use
How is quality assessment done?
Monitor QC and PT results, specimen rejections, complaints, corrected reports and turnaround problems. Reassess the plan after any error, and after any change such as a new reagent formulation, staff turnover or a new testing site.
What does an IQCP template include?
Test, test system, location, and the CLIA specialty and subspecialty
Eligibility check against SOM Appendix C, Table 1
A summary of the manufacturer's QC instructions
A risk assessment table: component, possible error, likelihood or impact, existing control, added control
The QC plan: control type, frequency, acceptance criteria and corrective action
The quality assessment plan: indicators, review frequency and reviewer
The director's approval signature and date, which must precede use
A review and revision history
How do IQCP and PT failures relate?
An unsuccessful PT event on a test covered by an IQCP is a quality assessment trigger. Investigate whether the risk assessment missed the cause, then document any change to the QC plan, such as more frequent external QC. Repeated PT failures can lead to CLIA sanctions regardless of the IQCP. See failed PT corrective action.
What can't IQCP be used for?
Waived tests, which follow the manufacturer's instructions only.
Pathology, histopathology, oral pathology and cytology, which are not eligible under Appendix C, Table 1.
Specialty-specific requirements that stay mandatory even in eligible specialties, such as immunohematology (§493.1271) and clinical cytogenetics (§493.1276).
Accredited labs should also check their accreditor's IQCP requirements.
What IQCP weaknesses do surveyors cite?
Generic templates with no lab data.
QC set below the manufacturer's requirements.
A missing or late director signature.
No ongoing quality assessment.
One plan covering different test systems or sites without assessing each.
Frequently asked questions
Is IQCP required?
No. It's optional. Labs can follow the default QC requirements in §493.1256(d)(3) instead.
Can IQCP be used for waived tests?
No. It applies only to nonwaived testing.
Who approves an IQCP?
The laboratory director, who signs it before use.
Can an IQCP require less QC than the manufacturer?
No.
When should an IQCP be reassessed?
After an error or PT failure, and whenever reagents, staff, location or the test system change.
Need an IQCP reviewed?
Sound Lab Consultants writes and reviews IQCPs using CMS guidance and your lab's own data.
Sound Lab Consultants provides lab director and technical consultant services, inspection readiness and mock surveys, deficiency and sanctions response, new lab startup, and waived-to-moderate/high complexity upgrades.