IQCP Risk Assessment Worksheet

1. Pick one test system. Name it, the analytes it runs under the plan and who is preparing the draft. Identical analyzers can share one risk assessment, but CMS wants differences in staff and location weighed, so a second site may need its own.
2. Gather what you already have. The package insert (intended use, limitations, specimen requirements, storage, QC frequency, interferences), the operator manual, your verification data, the last two years of QC (summarised per lot in the QC statistics calculator) and PT (see CLIA proficiency testing rules), temperature logs, rejection logs, complaints and competency records.
3. Walk the five components and record each hazard: what can go wrong, what the manufacturer says, how often it could happen and how much it would hurt the result, whether it can be reduced, and the control that reduces it. Each component opens the factors CMS's surveyors probe.
4. Write the quality control plan from those controls: the number, type and frequency of QC and the criteria for an acceptable result. Then list the quality assessment checks that will show the plan is working.
5. Print it and give it to the laboratory director. The print is laid out for review, carries a signature and date block, and is a draft until the director signs it.

Want to see a finished one first? “Load CMS's workbook example” fills the worksheet with the fictitious magnesium lab from CMS's own IQCP Workbook. Everything stays in this browser tab and its local storage: nothing is sent to AssayDeck.

In CMS's words, “An Individualized Quality Control Plan (IQCP) is an alternative quality control option permitted under CLIA” (CMS, IQCP page). IQCP is CMS's current alternative QC option for nonwaived testing. Without it, the Workbook says, a lab “must test two levels of external controls on each test system for each day of testing” and follow every specialty rule; see how often to run QC.

An IQCP has three parts, and the worksheet has one for each:

• Risk assessment: the identification and evaluation of potential failures and sources of error across the whole testing process.
• Quality control plan: the written procedure that controls the quality of the test, built from the risk assessment.
• Quality assessment: the ongoing monitoring that shows the plan is working, and the trigger to revise it.

IQCP does not have to mean less QC. The Workbook says plainly that adopting one “will not necessarily reduce your QC testing practices”, and no plan may be less stringent than the manufacturer's instructions. The choice comes up when the manufacturer's QC instructions are silent or ask for less than CLIA's control rules: then, CMS says, the lab follows the regulation as written or develops an IQCP. The Workbook's example lab picks its magnesium analyzer for exactly that reason, an internal control on every reagent disc and a recommendation to run external controls at least every 30 days.

CMS's survey procedures (State Operations Manual, Appendix C) require the risk assessment to cover, at a minimum, five components, across the preanalytic, analytic and postanalytic phases, for each test under IQCP:

• Specimen: patient preparation, collection, labeling, storage and stability, transport, processing, acceptability and rejection, referral.
• Test system: sampling, clot and interference detection, calibration, optics, pipettes, barcode readers, function checks, internal and external controls, software, the LIS link, result reporting. CMS adds test volume and whether results are used for screening or diagnosis.
• Reagent: shipping and receiving, storage, expiration, preparation, deterioration, lot-to-lot variation, mixing kits or lots. Controls and calibrators count here too.
• Environment: temperature, airflow, light, noise and vibration, humidity, altitude, dust, water, power, space, and transport in a mobile lab.
• Testing personnel: training, competency, qualifications, staffing. Testing personnel must take part in the assessment, though not every one of them.

For each hazard CMS asks the lab to “evaluate the frequency and impact of those failures and sources of error on test quality”. It does not give a scoring scale, and the Workbook's own example rates nothing. The worksheet's rare / sometimes / often and minor / moderate / serious are an example scale to help the director see which hazards need the strongest control; use your lab's own scale if it has one.

The personnel component is where competency records do double duty; the competency assessment form covers the six CLIA elements the Workbook's example lab found missing.

• Nonwaived tests only. That means moderate and high complexity (see how CLIA sets test complexity). IQCP is a way to meet the analytic systems QC rules; waived tests follow the manufacturer's instructions instead.
• Most specialties. CMS's Table 1 lists the specialties and subspecialties that are not eligible: pathology, histopathology, oral pathology and cytology. Chemistry, hematology, urinalysis, microbiology, immunology, immunohematology and the rest are.
• Never below the manufacturer. Whichever option you choose, CMS does not permit QC “less stringent than those specified by the manufacturer of the test system”.
• More QC at the start. For a new test CMS encourages running controls more often during initial implementation, so problems show before the plan settles.

Revisit the risk assessment whenever one of the five components changes: a new analyzer, a new reagent formulation, a move, staff turnover. A testing failure does the same: CMS expects the lab to investigate, look back at every patient result since the last acceptable QC, and update the risk assessment and plan if needed.

Choosing the control rules and how many controls a run needs is part of the plan's acceptability criteria. The sigma metric calculator turns your bias and CV into a rule choice; Westgard rules explained covers what each rule catches, and the Levey-Jennings chart maker applies them to your runs. Calibration, part of the test system component, has its own six-month check in the calibration verification calculator.

• Nonwaived labs meet the analytic systems rules in §§ 493.1251 to 493.1283 “unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing” (§ 493.1250). IQCP is that procedure. The rest of Part 493 is mapped in CLIA regulations explained.
• The daily control rule opens with the same exception (§ 493.1256(d)): two control materials of different concentrations each day for a quantitative test, unless CMS approves an equivalent procedure.
• The director signs the plan before it is used: “Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use” (§ 493.1251(d)). The task may be delegated in writing; the responsibility may not.

At a CLIA inspection, surveyors cite a missing or thin risk assessment under D5445, missing documentation behind it under D5481, a plan without number, type, frequency or criteria under D5441 or D5469, and a plan used before the director signed it under D5407 (SOM Appendix C). A cited tag is written up on the Form CMS-2567 statement of deficiencies. Keep all risk assessment records for at least two years after the plan is discontinued.