CLIA Final Rule

Not only did we gather answers in our 2016 IQCP User Survey, we also offered them a chance to voice their opinions directly, in free form comments. Believe me, they didn't hold back!

2016 IQCP Users Survey - the Comments Section

July 2016
Sten Westgard

There were more than 40 lengthy comments added to the end of our IQCP survey. We tried to categorize them into praise, criticism, ambivalence, and somewhere in between.

The Positive Reviews

• "The implementation has decreased the usage of expensive QC."
• "For those tests that I have not yet developed IQCP we are having to daily QC and it is costing us a lot of money. This can easily make small laboratories costs go through the... roof."
• "The instrument IQCP in conjunction with existing SOPs ensures that we have every aspect covered. Collection to reporting. Good and thorough review."
• "Overall I like IQCP since greater emphasis is placed as it should be upon pre and post analytic phases of testing. Too often these key phases of testing are completely ignored by even good laboratories."
• "I found in doing these that most risk in any of these test systems is in the preanalytical phases. Those cannot be monitored by increased QC but can be helped by increased competency and oversight."
• "Documenting processes and looking at risk areas more in depth definitely instills patient quality results and confidence in testing."
• "IQCP did make us take an overall global view of our program."
• "Looking at the various risks was informative however, most were not related to running QC. Linking all of the risks to QC frequency does not make sense to me. Many of the risks are pertinent to most tests in the laboratory [regardless] of whether internal or external QC is performed. Waived tests also have many of the same risks but were excluded from the IQCP regulation. Those lab results are just as important."
• "Of the 15 or so IQCP's we developed, we identified ONE issue with a test system. This lead to a re-training of staff on one aspect of testing. We also discontinued some testing where we were unable to identify adequate control mechanisms. All around, it was a decent exercise to have a "fresh" review of our EQC tests, however, the hours and hours (and hours) of work were not worth the effort."
• "This seemed to be a quite labor intensive process with no real measurable improvement or benefit. It was a lot of work, but we gained valuable insight into all of the risks of the testing process."

IQCP is what we’ve been doing all along

• "Developing an IQCP did not address or reveal anything beyond what Good Laboratory practices dictate and regulatory guidelines mandate."
• "I feel in a well-run laboratory all of the risks should have already been addressed before the implementation of IQCP."
• "I don't want the IQCP document to take the place of the procedure. All the limitations (risks) should be part of that document with whatever can be done to mitigate those risks."
• "It was a lot of work to justify practices already in place."

What we found when we developed our IQCPs

• "Different tests had different IQCP outcomes. Some tests required much more QC oversight. Some were fine at two levels per 30 days. Most went to weekly QC."
• "It was a learning experience and still is. Some positive QA things came out of the process. Some others were unchanged basically because of the type of QC available for the test and its limited usefulness. (ie ACT liquid QC). Although a lot of time and effort was put into the IQCP - it would take much more time watching processes in the various locations to do it the way it should probably needs to be done."
• "Many hours spent arriving at the same conclusions we were are already familiar with or had already identified as issues. The only plus I saw was the increased accountability and understanding management has that utilize point of care have."
• "In our clinic lab IQCP did not change the amount of QC we do, but we are documenting more."
• "Our QC person decided to do them all herself, she wanted them to all look the same. Did not share with the departments. Our next inspection should be interesting."
• "All 3 IQCP's I developed involved instruments that utilized single use test devices. Aside from pre-analytical errors, much of the control is built into each test device and it's interaction with the analyzer. While IQCP helped me understand what those controls are, these types of platforms do not lend themselves to improvement by running external liquid controls any more frequently. Electronic QC devices are sufficient for monitoring the functionality of the analyzer."
• "I did IQCPs for FFN and Amnisure. The major issue that was discovered was that the collection personnel (nursing) weren't aware of all the factors that affect collection, such as timing the collection properly, interferences in collection that could contaminate the swab, and other physiologic conditions that could affect collection. I developed a training module for all L and D nursing staff for Amnisure. We also added collection information into both the amnisure and FFN collection kits that we send to the floor. In the laboratory, there were no risks that were determined. However, I am now looking at all rejected sample reports, physician complaints, as well as corrected reports on a daily basis. This is no different than we have always done with these reports, except that they now are documented on the IQCP. The collection findings have been a benefit to our quality, the laboratory practices have shown no benefit to quality."
• "Choosing to perform 2 levels of daily controls or develop an IQCP not to be less than manufacturer's requirements still does not prevent resulting errors in all potential pre-analytic, analytic or post-analytic phases. QC performance is a wrinkle in time to the complete picture."

A Waste of Time and Money

• "Waste of time"
• "IQCP is unnecessary, a waste of time and money."
• "I felt that the whole process was a waste of time for microbiology labs."
• "For hospitals it was a waste of time and effort."
• "I think it was a waste of time. More unnecessary paper work."
• "I think IQCP is a total waste of time. It is just putting into writing what we already do as far as QC. The manufacturer has already had to prove the stability of the test system. It was just a lot of busy work typing up stuff that changed nothing."
• "TIME CONSUMING EXERCISE."
• "Very time consuming for very little benefit"
• "The process is too rigorous for things with well-functioning internal controls. It added work to processes that used to follow easier EQC processes and has not provided any additional benefits."
• "We are still struggling to understand the advantage of IQCP. It is a lot of work, a lot of money with no return in terms of time or quality."
• "I still feel that forced IQCP is excessive and unnecessary. As a rule, I review all "new" tests to be implemented in the lab, modify as appropriate "QC" requirements as I deem necessary, and assure that all methods are validated prior to implementation. Personnel are properly trained before use[.]"
• "I'm sure IQCP is good for something; I just haven't seen it yet. Especially with all of the safety mechanisms, regulations, etc that are in today's testing/labs. I just think it is time consuming fluff."
• "I understand what the intent of IQCP was, but I think it could give labs a false sense of security if they don't seriously examine the risks associated with their tests. I am also concerned that because of CAP's peer-inspection process, it will be very difficult, if not impossible, to standardize the way IQCP is inspected. Individual labs will be at the mercy of inspections that are either too lax or too harsh."
• "While I understand the intent of the IQCP, a well-run lab already has in place checks to monitor possible points of failure. Putting these in another document just adds effort without adding much in the way of true quality control."
• "Seems like an exercise in compliance without a corresponding benefit. Kind of like MU. Busy work without the "pay back""
• "This was a whole year of massive effort that was a huge distraction from my normal QA oversight duties. It yielded no measurable benefit. We are a professional lab that takes all aspects of the preanalytical, analytical and post analytical processes very seriously whether it is a waived or non-waived test. Many of these kit tests are the same regardless what package they come in. But the less expensive (non-waived) one needs an IQCP. It makes no sense."
• "Seems a lengthy process that really had no benefits to overall quality in the lab."
• "In my experience it has been purely cosmetic. Little effort was put into it and it has been treated as just one more thing to get done, rather than an opportunity to find defects in the processes."
• "I don't believe an IQCP was needed for Siemens Rapid Point 500 Blood Gas analyzers. But due to differences in interpretation by inspectors, I wanted to be prepared for our next inspection. We were already doing everything in the IQCP, the CAP forms were used to document in an IQCP format."

Implementation and Regulatory Problems

• "Initially there was very little information/ guidance on developing IQCP. As time got closer, much more information was made available."
• "Did not have detailed guidelines from regulatory agencies soon enough. Since we didn't find new risks, the effort seems redundant."
• "After all the hype that went into the IQCP I feel that before it was presented to the Professional world it could have been better organized. Questions upon Questions from various individuals prove that it was not an easy concept or simply presented."
• "CAP was slow in providing updated standards and did not do so until after the implementation year started. They did not publish forms until a month or very soon before our survey. We were surveyed Jan 2016. Required a great deal of nurse education also because of the changes to POC non waived tests. We developed a policy and included nurse leaders from the start to help avoid problems or pushback from staff. It seemed to work well for us. Still working through reviews as annual evaluations are creating more work to assimilate all QC data for the ongoing effectiveness assessment."
• "We need to educate inspectors of the detail requirements more."
• ".... IQCP idea could be great if the lab is provided with appropriate resources. There are some questions still remain [unanswered ]:
  • 1. CMS must define the data being analyzed for IQCP in terms of duration (For 3 months or 3 years, for example - may be depending upon workload).
  • 2. The option for not developing IQCP is running 2 levels of external controls everyday - liquid controls only assess analytical aspect and that shall not justify the problem which could be at pre-analytical or post-analytical phases.
  • 3. It could be a great start to have IQCP as an alternate to EQC but honestly speaking, after the experience in our lab, it does require for all the existing test systems.
  • 4. If CMS can collect the data of the Unacceptable findings during IQCP development as a survey, it shall be a great study to understand where the most issues lie in the test process in today's date...."

Conclusion? - you can reach a conclusion yourself. These labs who participated in the survey already did.