IQCP for POCT

POCT

Quality control continues to be problematic for point-of-care tests (POCT). According to literature, 75 percent of arterial blood gas (ABG) testing errors can be attributed to pre-analytical errors.¹ And CMS has noted that 19% of POCT operators were not trained for the testing they were performing. Such inconsistencies spell trouble for lab managers responsible for overseeing POCT quality.

As of Jan. 1, 2016, CMS will open the door to Individualized Quality Control Plans (IQCPs), which are applicable to all testing specialties-with the exception of pathology and cytology-for all non-waived tests. These individualized plans take the approach that every different test, in every different setting, performed on every different instrument, by every different staff may require unique quality control based on specific risk assessment and management.

Quality control expert Sharon Ehrmeyer, PhD, MT(ASCP), is professor of pathology and laboratory medicine at the School of Medicine and Public Health, University of Wisconsin, Madison, Wisc. She has helped to de-mystify IQCPs via a recent AACC industry workshop and further shares her insights in this Q&A specifically geared towards ADVANCE readers. She offered the following disclaimer pertaining to her answers: “Please note that I am addressing only test methods/devices outside the microbiology specialties. CMS recently removed all references to CLSI guidelines in the CLIA regulations. This greatly complicates micro methodologies and QC practices since sites have relied heavily on CLSI documents.”

ADVANCE: IQCPs are not “required.” But under what circumstances should an IQCP be developed for point-of-care testing?

Ehrmeyer: It must be noted that the IQCP option is voluntary. Test sites, typically those at point of care, wanting to implement or continue to use a non-waived testing device and rely solely on the device’s built-in quality assessments to meet daily QC requirements, will need to develop and follow an IQCP. Test sites not wanting to develop an IQCP will need to perform external QC for each analyte on days that patient testing is performed, regardless of the test device’s built-in quality assessments.

ADVANCE: What are the challenges to setting up IQCPs specific to POCT?

Ehrmeyer: There seem to be several challenges:

• Just getting started. There is often a prevailing perception that the task of developing an IQCP is too difficult and too time consuming. It is not!

• Buy-in for all involved. To develop an IQCP, there must be approval of the process and outcome from the test site director. The director certainly must realize that this is regulatory and will be inspected, and perhaps, cited for deficiencies. The director must sign-off on all final IQCPs. Test site staff may need convincing too. Staff, depending on the number to be ðdeveloped, will be needed to help in the process. The POCT coordinator really can’t do it alone.

• Establish a process or framework that can be followed for all IQCPs to be developed. For the rare site that only needs to develop one or two, this may not be necessary. But if several IQCPs are needed, a roadmap is needed to establish how to conduct the process; collect, document and store information, etc.; and how decisions, such as the quality control plan and the presentation of information in the IQCP, will be made. Do not reinvent the wheel for each IQCP.

• Limit the risk assessment (RA) process. Thinking that the risk ðassessment process must leave “no stone unturned” slows down the assessment and can give staff that “never ending, impossible” feeling. Sites should start with obvious potential errors impacting test quality and deal with those. At least for the initial IQCP (further changes can always be made), forget about discovering the “once in a lifetime” potential errors.

• Going it alone. While the IQCPs need to be device- and site-specific and developed by test site/organization personnel, this does not mean that available “tools” cannot or should not be used. The many tools now available range from commercial products to accrediting organization (AO) workshops and programs to manufacturer- and device-specific tools. There is a lot of quality information available for test sites to use in the development of their IQCPs. It is essential that test sites contact their manufacturers for available tools and information.

ADVANCE: Are there any circumstances in which you would advise against a POCT IQCP?

Ehrmeyer: Yes, in the cases of:

• tests that the manufacturer specifies analyzing at least two external QC materials per test per day of testing. Test sites must follow manufacturers’ directions and two external QC materials per test per day of testing usually meets the minimum regulatory QC mandate.

• low or lower volume tests where analyzing external QC materials is available, not problematic or not too expensive.

• testing done on testing devices having inadequate built-in quality assessments to ensure test result quality.

ADVANCE: What are the “rewards” that a POCT program can reap from having an IQCP in place?

Ehrmeyer: The rewards are found in vetting the many policies and procedures that impact the entire testing process. If the IQCP development process is done right, then test sites will totally understand the entire testing process. Once those significant errors in the RA step (not eliminated by current practices) are identified, and test sites modify and/or add additional practices accordingly, test sites should have confidence that their policies and procedures ensure quality throughout. So, in reality, the RA step is another check on the validity of a test site’s (POCT program’s) current practices.

The Quality Control Plan (QCP) focuses primarily on analytical quality. Through the IQCP development process, the test site should know if and how the testing device ensures quality. From the process, sites can decide if they should rely entirely on the manufacturer’s built-in quality assessments. Or, are additional quality practices, such as external quality control and operator training, required? The QCP really tailors the daily QC process to each site and device. Of course, the test site can never do less than what the manufacturer requires.

CMS states that the rewards or benefits of IQCPs:²

• ensure quality throughout the testing process

• allow “customization” of QC by the test sites

• allow use of manufacturers’ built-in quality assessments to meet the required daily QC requirements

• avoid the default QC of 2 levels of external QC/test/day of testing. An IQCP can reduce daily QC to less than the stated default, but daily QC can never be less than what the test manufacturer specifies.

ADVANCE: Are there any basic rules of thumb for setting up a POCT IQCP (i.e., where do lab managers start to wrap their heads around this)? What does it look like in terms of cost, time or staffing to pull it together?

Ehrmeyer: As the IQCP is test-, device- and test situation-specific, the costs and staffing required will differ from site to site. Don’t be uninformed and/or misguided. The basic rule of thumb for test sites is to know the development process and know organizational, regulatory and clinical requirements for their testing sites.

Follow “instructions” for the development process. For CMS test sites inspected for CLIA compliance, this means following the information in Individualized Quality Control Plan (IQCP): A New Quality Control (QC) Option.³ For sites accredited by AOs, this means following the appropriate AO requirements as well as the information/examples noted in the source listed above, as this information will be helpful. It is important to contact manufacturers for detailed test device information and available IQCP development tools. Information abounds from professional organizations, the government and professional experts such as myself on IQCP development. It is ðimportant to access at least some of these. Many of the materials and webinars are available, typically for no charge.

Valerie Neff Newitt is on staff at ADVANCE. Contact: vnewitt@ðadvanceweb.com

References

1. Bonini P, et al. Errors in Laboratory Medicine. Clin Chem 2002, 48(5):691.

2. CMS. Individualized Quality Control Plan (IQCP). Available at: www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCPbenefits.pdf

3. Center for Clinical Standards and Quality/Survey & Certification Group. Individualized Quality Control Plan (IQCP): A new quality control (QC) option. Available at: www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-54.pdf