CLIA Final Rule

In addition to the IQCP survey questions, there was an opportunity for participants to speak directly and openly about their experience with IQCPs. It makes for some interesting reading, to hear the unfiltered responses of laboratorians...

The 2015 IQCP survey: US Laboratories Speak Out!

Sten Westgard, MS
June 2015

In addition to collecting the survey data from US labs on IQCP, we also offered participants in the poll ample opportunity to share their views in open comments. While the marketing on IQCP has been glossy, and the trade journals have provided a rosy picture of the benefits of IQCP, no one seems to have heard the bench technologists, the rank-and-file laboratorians who are actually going to have to implement IQCP. And judging from these responses, they are not happy with the impending IQCP regulation.

We've divided the responses up into different categories. A few responses were edited because they were not germane to IQCP, but the vast majority of comments are faithfully reproduced here (anonymously to protect the innocent and frustrated). See which one agrees with your opinion.

Primal Screamers

"ARGH!!!!!!!!!!!!!!!!!!"

"The committee is slowing everything down."

"Grrrrrrrrrr"

"What is the point of all this? Does it have any real value or just another regulatory headache?"

"One more government project required to address practices that have been in place and sufficient for years."

"It is confusing and I really don't see the utility of such an undertaking."

"No, still mostly in the dark."

"Very confusing."

"Just wish it was more understandable!!!!!!"

"??????"

Compliance Cravers

"Just tell me what our lab needs to do!!"

"IQCP makes my head hurt, I want an easy button."

"Not sure why this is being foisted on already overworked, understaffed labs. I'd like to know what is the minimum that has to be done to comply and what is mandatory. Also, what is the benefit of changing to IQCP?"

"Our CLIA Regional Director keeps assuring us that we will be provided ALL the necessary training well before they will expect to see it in use...that was 6 months ago, still waiting."

"As with many Federal brainstorms, this is an unwise move in that incompetent labs can manipulate poor performance into appearing to be acceptable. A totally idiotic principle."

"Very confused at the daunting task of keeping the lab in compliance."

"What is the purpose of moving from EQC to IQCP?"

"Even though I have attended conferences and webinars, there appears to be a lot of confusion even with the regulatory agencies. How will they survey?"

"California Laboratory Field Service's current position is that the use of EQC and the replacement IQCP is not an available tool to California non- waived laboratories under the California's laboratory Regulations."

"My State (NJ) DOH currently will not allow IQCPs. We don't know where that leaves us."

"[We are a] CLIA Waived Lab - so seems if CLIA required QC is adequate - will continue as is."

"I wish CAP would get their guidelines out sooner rather than later!"

Small Lab Strugglers

"Looks too expensive for the small critical access labs."

"I don't understand how small, rural hospital labs can perform studies to implement IQCP."

"The new IQCP requirements seem extreme for our low volume (55-60/year ABG) pulmonary office. We already lose money on every draw keeping up our EQC program which I think is more than adequate and more than the manufacturer currently recommends."

"I believe this concept is "above the head" of the average small hospital laboratory, many of whom have no consultants or clinical pathologists, and much of the staff has no advanced training. Our lab is staffed mainly by MLTs. The MTs are bench techs who mainly perform testing, no administrative functions. I am the Point of Care Coordinator and was aware of IQCP when it was first mentioned. The lab staff for the most part have never heard of it."

"I welcome the concept of IQCP but am worried that it will be made into a 'one size fits all' quality program. I direct four laboratories. One laboratory has one medical technologist, two has two medical technologists, and one has seven medical technologists. There are no "teams" available to complete complex means of compliance that larger facilities may have available. Yet every laboratory must meet the same requirements for compliance. How can this be done simply with limited personnel?"

"It is very confusing with very little training and especially difficult for labs that are small or have limited staff."

"I understand that this should be addressed for all QC but we do not have the manpower to do that."

Articulators of Mass Frustration

"I still don't understand IQCP even with listening in on a webinar. We follow all QC guidelines for waived and non-waived testing from the manufacturer inserts/guidelines and it's my understanding that is all that I need. Clarification on the "investigation" piece would be helpful, but I feel like we're already there. Maybe I'm in denial and hoping that the two of us that will be working on this will maybe only have to edit our current QC policy to include language addressing IQCP."

"Does the federal government really think that this will improve the QC in our laboratory? From my experience, the State Inspectors didn't even know how to evaluate EQC. My lab had a writeup on all our waived serology testing because I had not implemented EQC. Waived Testing!!!! We already daily use IQCP, just not a written specific step in a procedure. It's how I have always monitored QC, daily on every test in our lab. Just the idea of re-writing every procedure with "RA" listed. Hours of "Poor Me". I just feel that again, inspectors will have no idea how to determine if our "RA" is adequate for our QC program. Another waste of lab time, money, and many, many extended procedure re-writes."

"While the intent of this change may have been good, the amount of work needed to implement and maintain it in a working laboratory is daunting. I wish I could see that it is going to improve patient care but frankly I don't believe for a minute that this initiative is going to do anything but burden our already busy and under-funded laboratories."

"Once the IQCP plan is in effect, how do you review and document the risk assessment? I can see me establishing it and then falling back to the traditional liquid qc, staff performance standard type of review."

"Using an IQCP instead of the CLIA requirements causes the facility to take on a lot of risk, which is why [we] are reluctant to use IQCP."

Dissatisfied IQCP Tool-Boxers

"The CLSI guidelines and tools are expensive and still not clear. I feel like I'm on my own. Will have my Joint Commission survey review what is done to ensure I am one the path they expect us to be."

"Guidance is very vague and abstract. Most of the places that we have heard about implementing it have a team and multiple resources, just not feasible for most laboratories that already have staff stretched to the limit and administrations unwilling to invest resources in it. Specific instructions are needed to make the process simple and accessible for all laboratories."

"I feel that the details are so "grey" as to what they expect from us so it is hard to develop any plan without a rigid guideline of what really needs done. In our lab it is seen as something that is left for interpretation."

"It is frustrating that, with something so important, there is so little new/applicable information and/or clearly defined expectations available.
Laboratories need straight-forward, cookbook-type instructions for IQCP. It is not feasible in the age of lean staffing to accomplish the risk assessments without clear and simplified instructions."

Pleaders for Practical Help

"In your opinion is IQCP for EQC methods just the beginning? Can we look forward to a whole-lab enforcement/implementation in the future?"

"When is the deadline before CMS starts to deny payment of lab tests?"

"Do you have a list of references of people or agencies that can write IQCPs working in conjunction with labs?"

"Unsure of exactly which platforms it will apply to and what model will work for us?"

"Don't know enough to ask questions."

"We need more knowledge and tools for the risk assessment."

Silver Liners: Laboratorians making progress and/or adjusting to IQCP

"It's not rocket science, it's dogged persistence and detail."

"Easy to understand, easy to implement and it will be popular."

"It's a good process to make you look at your QA system as a whole."

"Everyone is so upset over this but I don't understand the big deal. I understand IQCP to be the lazy way to perform QC but with the support of a detailed risk assessment analysis and report. If you don't want to put in the effort continue performing the gold standard of CLSI guidelines."

"My initial impression is that IQCP will be more a matter of rewriting our P&P manuals to incorporate the "language" more than it will be changing how we perform quality control."

"My biggest challenge is coming up with ways/ ideas/ tools to monitor the IQCPs that I am developing from the risk assessments - need more info and guidance."

"From everything I've read regarding IQCP, we are already compliant. We perform anywhere from 2 to 3 levels of controls for each non-waived analyte we measure. We are a Joint Commission accredited, CLIA licensed, hospital based laboratory. We have met the requirements of our accrediting organization as of February 2015. Not a word was mentioned by our JACO surveyor about IQCP. What more would we need to do to be compliant with IQCP?"

"The first one caused much angst. Hoping to use the first one to quickly knock out the remainder of them."

"Our laboratory was already using risk management tools, so we already had a lot of data to use IQCP."

"Developed IQCP for serum pregnancy test with the assistance of our lab inspectors. Now developing plans for similar and more complex tests."

"In the end, based on our analysis, we have only changed the frequency of QC for only a couple of tests. I feel the complexity of the IQCP reports makes it less likely that anyone would refer to the actual plan. Most technicians will look at the package inserts before going to the IQCP plan for assistance with issues. There have been little to no deficiencies for any of our kit tests throughout my years as a technician, and doubt that an IQCP plan is going to make a significant difference in our day to day activity. Granted, there are many potential deficiencies with every rapid test, but given the fool proof quality control material, cook book recipe instructions, and internal control lines, makes it difficult to believe that many facilities will need to further assess or change their procedures based on an extensive IQCP report.... Trying to be optimistic!"

Conclusion

The survey results can be read one of two ways. It depends on whether you want to be optimistic or pessimistic. An optimist would be heartened by the level of awareness - a majority of the laboratories know that some regulatory change is coming. The pessimist would point out that most labs haven't taken any action, appear confused, and are running out of time.

A realist would point out that IQCP has all the hallmarks of an unfunded mandate. A high burden with little hope of a properly funded or resourced solution. This is a recipe for an implementation failure. Too few techs with too little money are going to be tasked with the responsibility of developing IQCPs. The result is likely to be incomplete risk assessments, inadequate quality control plans, and insufficient monitoring. A lot of residual risk is likely to get passed on to the patient.

As CMS has been saying over and over, IQCP is a choice. If labs have another choice, they should strongly consider it. If they don't have a choice, they need to do better than the survey results here: they need to invest more, plan more, and monitor more.