Labs ready to implement a risk management approach to quality control
By Karen Appold
Years in the making, this January marked the beginning of an education and transition period for labs seeking to implement an individualized quality control plan under new guidelines adopted by the Centers for Medicare and Medicaid Services (CMS).
The new program will put to rest many years of wrangling over the type of quality control programs that should be required of laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The new program will permit laboratories to customize their quality control plans according to their test methods and use, environment, and personnel competency, while maintaining the option of conducting quality control according to the requirements of the original implementing regulations for CLIA.
- Customizes a lab’s quality control plan for each test in its unique environment.
- Optimizes the use of electronic and integrated controls.
- Offers laboratories flexibility in achieving quality control compliance.
- Adapts to future advances in technology.
- Incorporates other sources of quality information.
- Strengthens manufacturer-laboratory partnerships.
- Formalizes risk-management data already maintained within the laboratory.
- Provides equivalent quality testing approach to satisfy CLIA quality control regulations.
CONTROVERSY AND PROGRESS
In many ways, it was the inadequacy and inflexibility of the original CLIA requirements for quality control that led to the development of the new program. In its simplest expression, those regulations required labs to test each quantitative procedure twice daily using external controls at two levels of concentration. But some labs soon found that this procedure alone was not enough to prevent quality problems from arising, while others chafed under the required procedures that did not accommodate the growing adoption of internal quality control systems in new analyzers.
CMS attempted to address these concerns in the January 2003 final version of the CLIA regulations, by using its flexibility under the regulations (42 CFR 493.1250) to approve new procedures for equivalent quality testing. The program that emerged—termed equivalent quality control (EQC)—was controversial from the very beginning. Although the program provided a path by which labs could reduce the amount of quality control testing to be performed on a daily basis, many found the requirements to qualify for reductions too strict and inflexible, and some still found the program too lenient in areas where quality issues were likely to arise.
A breakthrough in the field came through the consensus standards-writing efforts of the Clinical and Laboratory Standards Institute (CLSI), with its October 2011 publication of an evaluation protocol titled “Laboratory Quality Control Based on Risk Management” (EP-23). Itself long awaited and years in the making, the new protocol provided CMS with the model that underlies its latest venture in laboratory quality control.
EQC NO MORE
Stepping away from the previous EQC framework is a move that has support in the laboratory community as well as at CMS.
“EQC was the first step toward an alternative form of quality control,” says Judith Yost, director of the CMS division of laboratory services. “But EQC is very rigid; it is a step-by-step process that labs must follow exactly.
“EQC is also very narrow in scope; only a limited number of test types can be included. And EQC only looks at analytics systems—that is, quality control within the testing process,” Yost adds.
By contrast, says Yost, CMS’s new individualized quality control plan (IQCP) is “new, improved, and will work in the present as well as into the future. IQCP is very flexible and open; each lab decides what will be included in its quality control plan.”
In addition, says Yost, IQCP covers all CLIA specialties and subspecialties except pathology, histopathology, oral pathology, and cytology. And it embraces the entire testing process, from the preanalytical to the postanalytical phases.
The EQC program permitted labs to increase their reliance on analyzers’ internal controls, and correspondingly to decrease daily testing using external quality controls. For labs that could meet the qualifications, the intended result was a net reduction in daily testing activities. IQCP does not perpetuate this trade-off. Labs are required to develop a suitable quality control plan that may or may not make use of internal quality controls—and may or may not reduce a lab’s overall quality control activities.
“IQCP is not necessarily intended to reduce quality control requirements,” says Yost, “but it is intended to ensure effective quality control for each laboratory and the tests it performs.”
Labs that are currently using EQC procedures are permitted to continue doing so throughout the 2-year education and transition period. “Labs can use data collected as part of their EQC program for making the transition to IQCP, so that will be very helpful,” says Yost. “However, when the education and transition period ends on January 1, 2016, labs will no longer be able to use EQC procedures.” CMS has specifically said that there will be no grandfather period.
FROM PROTOCOL TO GUIDELINE
CLSI’s copyrighted evaluation protocol, “Laboratory Quality Control Based on Risk Management,” provided a significant underpinning for the development of CMS’s IQCP initiative, but Yost emphasizes that the two documents aren’t identical.
“They are not one and the same,” Yost notes. “EP-23 is an excellent resource document. However, you don’t need to have EP-23 if you wish to adopt IQCP.”
According to Yost, CMS early on decided that it would be too onerous and time-consuming to revise its approach to quality control by amending the CLIA regulations. Instead, the agency took advantage of the opportunity to update the regulations by means of interpretative guidelines. “Instead of having to change regulations every time technology changed, we gave ourselves permission to update protocols by means of our interpretative guidelines,” she says. So long as the protocol provided a means of equivalent quality testing, that approach was specifically permitted by the terms of the CLIA regulation.
Because the IQCP program is not a regulation, adopting the IQCP approach is entirely voluntary. Once published in Appendix C of CMS’s State Operations Manual, however, IQCP will become an enforceable quality control approach applicable to all labs that have chosen to use it.
However labs may choose to approach their quality control activities, most of the existing CLIA quality control and quality system concepts won’t change. State and local regulations will still apply. And the lab director or a delegate will continue to be responsible for the lab’s quality control activities, including:
- Delivering accurate and reliable test results that are appropriate for patient care.
- Ensuring that the laboratory’s plan meets the requirements of the IQCP guidelines.
- Signing and dating the IQCP when it is implemented and updated.
Moreover, CLIA’s current “default” quality control regulations will remain in effect. At the end of the education and transition period, all existing and new test systems will have to comply with either the “default” CLIA regulations or an individualized quality control plan covering every aspect of quality control.
“With CMS’s equivalent quality control (EQC) protocols on the way to being replaced by the new individualized quality control plan (IQCP) program, it is important for laboratories to familiarize themselves with the new guidelines,” says Rose Mary Casados, president of COLA Resources Inc, an educational and training subsidiary of laboratory accreditor COLA.
“There is a great deal of anxiety surrounding the concept of IQCP,” says Casados, “so laboratories need to begin their education process now.”
CRI offers a wide range of educational resources to help labs transition to the new IQCP environment, says Casados. CRI’s IQCP E-optimizer is a software tool that provides laboratories with a guide on how to perform risk assessment and develop an IQCP. The CRI Implementation Guide is an all-inclusive manual that assists laboratories in implementing an IQCP specific to their needs.
“CRI will be conducting a number of workshops and seminars, and can also provide key educational tools for laboratories,” says Casados. “Although the education and transition period has just begun, now is the time to get started.”
CRI IQCP Workshops
- May 8, 2014: Dallas, Double Tree by Hilton
- July 15, 2014: Columbus, Ohio, Sheraton Columbus at Capitol Square
- October 15, 2014: Orlando, Fla, Buena Vista Palace Hotel and Spa (in conjunction with the CRI annual Symposium for Clinical Laboratories)
According to Yost, CMS decided at the outset of the IQCP project that it would not establish minimum levels of quality control to be performed by labs that chose to adopt the IQCP approach. “When you set a minimum, everyone goes there,” she says. “We left it up to the labs. However, performing no quality control activities is not acceptable. And the frequency can’t be less than the manufacturer’s instructions.”
Within the framework established by CMS’s guidelines, labs can create IQCP programs that offer multiple advantages. The guidelines permit labs to customize their quality control plans for each particular test and the environments in which they are performed. The guidelines also allow labs to use integrated or electronic controls as part of their quality control plan.
“There is tremendous flexibility built into IQCP to allow the lab to meet CLIA requirements or those of an accreditation organization,” Yost says.
Although many familiar laboratory practices can be transferred to an IQCP program, the framework of risk assessment and mitigation provides new methods and criteria for determining how to implement quality control activities. “In essence, you’re taking processes that labs already undergo to make risk-management decisions about their quality practices, and putting them into a risk-assessment quality control plan—and then monitoring their effects,” Yost explains.
“Ultimately, the goal of the IQCP program is to improve the quality of laboratory medicine and patient care,” says Rose Mary Casados, president of COLA Resources Inc (CRI). “Because there is a lot to learn, it is imperative that labs begin the education process now.” At the end of January, CRI hosted the webinar “Everything You Wanted to Know about IQCP,” featuring Judith Yost. The organization is now making the webinar available as an online course at www.labuniversity.org.
During the education and transition period, survey teams will be instructed not to cite labs for quality control deficiencies except in case of immediate jeopardy, when serious quality issues are identified, or when a lab has failed to implement any form of quality control.
Labs should take advantage of that grace period, says Yost. “We want labs to start with the education and transition process as soon as they can.”
Karen Appold is a contributing writer for CLP. For further information, contact chief editor Steve Halasey at [email protected]