Kits / IQCP
IQCP Kit
An IQCP has three parts: a risk assessment, a quality control plan and a quality assessment. Surveyors look for all three, for evidence that the risk assessment used the laboratory's own data, and for the director's signature.
CMS and CDC publish a free IQCP workbook and it is worth reading. This kit is the finished document set in editable form, laid out so the three parts and the supporting data stay together for each test system.
Written for: Nonwaived laboratories that run controls less often than the default in the regulation and rely on an Individualized Quality Control Plan.
Look inside
What happens after you buy
- 1Pay securelyCheckout is run by Lemon Squeezy, which handles payment and any sales tax. Your receipt arrives by email straight away.
- 2DownloadThe receipt links to a zip file with every document in Word or Excel, plus a fillable PDF of each one. Open the Start Here guide first.
- 3Make it yoursOptional: drop the zip into the Personalize tool to add your name, CLIA number and logo to every file.
- 4Review and signYour laboratory director reviews, adapts and approves each document before use.
- 5Stay currentWhen we revise a file in the next 12 months, the updated version is available from your original order.
What is in the kit
| Doc no. | Document | Format |
|---|---|---|
| IQ-01 | IQCP Policy When the laboratory uses an IQCP, who prepares it, who approves it and when it is reviewed. | Word + PDF |
| IQ-02 | Risk Assessment Worksheet Specimen, test system, reagent, environment and testing personnel, each across the preanalytic, analytic and postanalytic phases. | Word + PDF |
| IQ-03 | Quality Control Plan Number, type and frequency of controls, acceptance criteria and the actions when controls fail. | Word + PDF |
| IQ-04 | Quality Assessment Review The ongoing monitoring that shows the plan is working, and the trigger for a new risk assessment. | Word + PDF |
| IQ-05 | Supporting Data Summary QC history, proficiency testing results, corrective actions and manufacturer information used in the risk assessment. | Excel + PDF |
| IQ-06 | Laboratory Director Approval Page Signature, date and annual review block. | Word + PDF |
Regulation behind each document
The middle column is our plain-language summary. Read the regulation itself before you rely on it.
| Citation | What it asks for | Addressed in |
|---|---|---|
| 42 CFR 493.1256(d) | The default control procedures, unless CMS approves an equivalent procedure described in Appendix C of the State Operations Manual. | IQ-01, IQ-03 |
| State Operations Manual, Appendix C | The IQCP procedure: risk assessment, quality control plan and quality assessment. | IQ-02, IQ-03, IQ-04 |
What the kit does not do
- A quality control plan can never ask for less than the manufacturer's instructions require.
- Accreditation organizations set their own IQCP rules and forms. Check yours before adopting this set.
Your director stays in control
These are templates, written so your laboratory director can review, adapt and approve each one quickly. Nothing is used until they sign it.
CLIA is a federal minimum. Your state, and your accreditation organization if you have one, may require more. We do not promise a survey outcome, and we do not give regulatory or legal advice. Read the full terms.