Posted by Sten Westgard, MS
Another shoe has dropped in the regulatory world. Recently, CDC/CMS issued their "how-to" guide for IQCPs, CAP dropped their checklist for IQCPs, and now the other major deemed accreditor has put out their IQCP guidelines: The Joint Commission.
So what is JCI doing about IQCPs? Join us after the jump
For those of you who have read the CDC/CMS and CLIA memos, the structure that TJC is proposing is very familiar. It's got a strong emphasis on the format of your IQCP records but not heavy on the substance of the IQCP.
For example, you need the three parts (1) Risk Assessment, (2) Quality control plan, and (3) Quality Assessment.
The Risk Assessment has to cover the key five components (1) Specimen, (2) Environment, (3) Reagent, (4) Test System, and (5) Testing personnel.
The IQCP must cover the total testing process: (1) preanalytic, (2) analytic, and (3) postanalytic.
TJC also reiterated that "Published or manufacturer data may also be included [in the risk assessment] but cannot be the only data source for the risk assessment" and that IQCPs must be developed for "each location throughout a facility."
But even a brief review of this finds a hollow center. No mention of what tools to use to make the risk assessment, determine the right control plan, or select the right quality assessment indicators to monitor the process.
At the AACC/ASCLS conference, TJC will be presenting these IQCP regulations. I encourage those who attend to ask the tough questions: What does a real IQCP look like? How likely is it that QC can really be reduced to once a month? How much power will inspectors have to judge your risk assessment?
We've also uploaded these TJC requirements to our downloads section. So you can download the CAP, CMS, and TJC documents on IQCP from one source.