American Association for Clinical Chemistry
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February 2008 Clinical Laboratory News: CMS Rolls Out New CLIA Policy Changes

 
February 2008: Volume 34, Number 2 


CMS Rolls Out New CLIA Policy Changes
What Labs Can Expect

By Phil Kibak

Five years after releasing the final quality control rules under CLIA, CMS last month instituted new policy changes that on the surface seem small, but which many laboratorians regard as significant. The agency announced in August 2007 that it now will cite labs that don’t comply with certain new 2003 requirements under CLIA, which previously prompted only an “educational” letter of notification about the problems identified. These include test method verification, maintenance and function checks, calibration, and calibration verification. Laboratories have had since 2003 to become familiar with these requirements, but starting January 1 they will no longer receive a letter giving them an opportunity to correct the deficiency before action is taken. However, just as with all other deficiency citations, laboratories have a chance to submit a “plan of correction” describing how the deficiency will be rectified, and if done in time, no action will be imposed.

The threat of a citation for these deficiencies does not appear to upset too many laboratorians. “In my opinion these changes will have very little impact since most labs are inspected by CAP, COLA, or the Joint Commission,” said Sharon Ehrmeyer, PhD, Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School (Madison). “Most labs are already doing these things and device manufacturers have protocols to ensure that their customers can fully comply with the regulations.”

But what has again stirred controversy in the laboratory community is CMS’s endorsement of equivalent quality control (EQC). Laboratorians also learned in the latest round of CLIA updates that CMS plans to keep EQC in force for the immediate future, until the QC policy under development at CLSI is complete.

“These changes are another incremental step toward full implementation of EQC, and the concept of EQC was a very significant change for labs,” noted Robert Murray, JD, PhD, Technical Consultant with Midwest Diagnostic Pathology (Park Ridge, Ill.). “Laboratory personnel are well acquainted with the notion that two external samples need to be run daily for QC. But EQC replaced that with the idea that maybe there are other things that can be done to reduce the risk of error as effectively or even more effectively.”

Changes Small, But Surprising

Accreditation standards do not mandate EQC, so laboratories can continue their current practice unchanged. “Most hospital labs are accredited by CAP. Long before CLIA came into existence, CAP had its own set of standards that incorporated concepts like PT, QC practices, and personnel standards,” said Murray. “CAP accreditation standards make implementation of EQC an option, so laboratories that choose to continue the traditional practice of running two levels of control daily may continue without change. Also, labs in doctors’ offices are accredited by COLA, which also has its own standards and also does not, to my knowledge, mandate EQC. So, life will not change much in these labs until the accrediting agencies adopt EQC.”

But Judy Yost, Director of the Division of Laboratory Services for CMS, says several accrediting organization have options for QC similar to EQC. These include COLA and the Joint Commission. She also notes that CAP has a flexible capability for labs to reduce external QC.

Ron Laessig, PhD, Professor of Population Health Sciences and Pathology at the University of Wisconsin (Madison) and Director of the Wisconsin State Laboratory of Hygiene agrees that not much will change for labs now. “These are very minor changes, but they tell you the way surveyors will carry out inspection activities,” he explained.

EQC Revisited

The 1992 CLIA regulations included “phase-in” QC requirements to enable previously unregulated facilities performing unmodified, moderate complexity testing the opportunity to understand and meet the new requirements. During the phase-in, these laboratories were allowed to follow the manufacturer’s instructions to meet the requirement to perform two control procedures per day. Between 1992 and 2003, the manufacturers developed functional or electronic checks or internal controls that in most cases monitored only limited portions of the test system and did not monitor the complete analytic process. The final rule, published in January 2003, combined the moderate and high complexity QC requirements into one set of standards applicable to non-waived testing. These regulations included a provision requiring daily testing of two levels of external control material, unless CMS approves an equivalent procedure in the State Operations Manual (SOM) guidelines. As noted in the 2003 regulation, the control procedures requirements were developed to monitor the accuracy and precision of the complete analytic process.

James Westgard, PhD, Emeritus Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School (Madison), a staunch opponent of EQC, suggests that changes in laboratory operations and personnel may have actually led to the development of EQC as an operational concept. “With the advent of CLIA rules in 1992, personnel standards were reduced, allowing many people to perform laboratory tests with minimal training and understanding of the testing process,” he said. “One area of great difficulty has been QC, as evidenced by CMS’s own data showing that five to ten percent of laboratory deficiencies are in quality control.”

The recent announcement from CMS is significant, he added, because it now declares that EQC will be recognized as “legal.” “That is,” he explained, “that laboratories following the EQC guidelines will be in compliance with the regulations. But that doesn’t mean it’s necessarily good laboratory practice. In fact, the EQC guidelines are not scientifically valid—how does a ten-day validation protocol prove that a method is sufficiently stable so that QC only needs to be run once every thirty days?”

Yost objects to Westgard’s characterization. “EQC was always legal under CLIA, under 493.1256 in the 2003 regulations. Labs have a choice to do two levels of external QC or EQC,” she explained. “In fact, the protocol has been in place since 2004 in the Interpretive Guidelines on our Web site. EQC has been used by labs successfully since that time with no evidence of harm.”

Westgard maintains that labs will tend to adopt EQC because it is the least amount of QC possible under CLIA. “CLIA provides three different QC recommendations—the lab should implement the right QC procedure to ‘detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance; monitor over time the accuracy and precision of test performance that may be influenced by changes in the test system performance and environmental conditions, and variance in operator performance.’ Second, CLIA provides a default of two levels of QC per day, which eliminates any need to think about the right QC procedure. Third, CLIA allows laboratories to implement a procedure—EQC—that allows reduction of QC to two levels once per month. That’s the preferred option that most laboratories will want to implement because that is the least amount of QC possible.”

But Westgard’s criticisms miss the mark, according to Yost. “Labs don’t live by QC alone. They are required to be sure that their overall quality systems—proficiency testing, personnel competency, and quality assessment—are all in good standing in order to continue reduced QC. And, they are still doing internal QC every day,” she explained. “It is only the external QC that has been reduced for EQC. Labs in hospitals and reference labs are not impacted by this policy since they are mostly high complexity and do much more QC than is mandated by CLIA. These policies impact mostly labs performing moderately complex tests utilizing robust technologies.”

Top 10 CLIA Deficiencies
Laboratorians may want to be especially aware of these areas, which are the most frequently cited laboratory deficiencies.
Regulatory Cite
Deficiency
Number of Labs
% of
Labs
493.1236(c)(1)
At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I or this part.
1,087
5.80%
493.1252(a)
Test systems must be selected by the laboratory. The testing must be performed following the manufacturer’s instructions and in a manner that provides test results within the laboratory’s stated performance specifications for each test system as determined under 493.1253.
1,066
5.69%
493.1289(a)
The laboratory must establish and follow written policies and pro-cedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283.
1, 018
5.43%
493.1252(b)
The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer’s instructions, if provided. These conditions must be monitored and documented.
965
5.15%
493.1251(b)
The procedure manual must include the requirements for specimen acceptability, microscopic examination, step-by-step performance of the procedure, preparation of materials for testing, etc.
925
4.93%
493.1239(a)
The laboratory must establish and follow written policies and pro-cedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements in 493.1231 through 493.1236.
789
4.21%
493.1291(c)
The test report must indicate positive patient identification, name and address of the laboratory where the test was performed, the report date, test performed, specimen source, result, and units of measurement or interpretation.
761
4.06%
493.1407(e)(5)
The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided.
713
3.80%
493.1283(a)
The laboratory must maintain an information or record system that includes positive identification of the specimen, date and time of specimen receipt, condition and disposition of specimens that do not meet the laboratory’s criteria for acceptability, the records and dates of all specimen testing including the identity of the personnel who performed the test.
638
3.40%
493.1252(d)
Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality.
633
3.38%

Total number of laboratories surveyed by CMS = 18,746
Data based on the most current survey conducted on or after January 12, 2004
OSCAR data as of 8/10/2007

Source: CMS

EQC the Same For Now

When EQC was first instituted, it was seen as a means of easing the burden on labs that might be financially strapped or have limited personnel resources because labs could reduce the frequency of performing QC. “But CMS came out in 2005 and admitted ‘we blew it’ with the concept of EQC,” noted Ehrmeyer. “They tried to offer a simple solution to what is a very complex problem, but it lacks scientific validity and is not appropriate in every case. Instead of retracting this concept, they are now trying to rationalize it.” However, implementing EQC remains an option, not a requirement, as long as the laboratory director reviews the manufacturer’s QC approach and says, based on 10 to 30 days of external QC data, that EQC adequately monitors the method.

“The idea to keep EQC is an interim decision that will be revisited when revised QC policies are in place,” said Yost, referring to forthcoming documents from CLSI. “We did admit that we needed policies and procedures for QC that are scientifically valid at a QC CLSI meeting in 2004–2005 and are continuing to participate and support a process to do so, using experts from industry, labs and government.”

Filing Complaints at Issue

In a highly subscribed December 6 AACC audioconference titled “New Developments in CLIA and QC,” Yost and James H. Nichols, PhD, Associate Professor of Pathology at Tufts University School of Medicine (Boston, Mass.) and Director of Clinical Chemistry at Baystate Health System (Springfield, Mass.), discussed other CLIA issues, including filing complaints.

In 2006, a review by the Government Accounting Office titled “Clinical Labs: CMS and Survey Organization Oversight Is Not Sufficient to Ensure Lab Quality,” government officials expressed concern over the limited options CMS offered for laboratory workers filing complaints related to lab quality. The report specifically cited anonymity concerns and unfamiliarity with filing procedures. In her presentation, Yost rebutted these issues and pointed to guidance in this area provided in revised Interpretive Guidelines, the CMS Web site, a soon-to-be-released brochure, a CMS letter directed to professional organizations, toll-free telephone numbers in State Health Departments, and CMS central and regional offices that can be accessed via e-mail, regular post, voice/telephone, and fax. “CMS uses a sophisticated data system to track complaints and every complaint made is followed up in some manner,” Yost said. Complainants wishing to file anonymously can do so, she added. Nichols added that labs should familiarize staff with the complaint policy and should post the contact telephone numbers to file complaints.

Yost and Nichols also reminded the audioconference audience about proficiency testing (PT) referral, stating that laboratory personnel need to be aware of circumstances that could place the lab in jeopardy. Intentional or unintentional PT referral for either regulated or unregulated analytes can result in the most serious CLIA penalties, including loss of CLIA certificate for one year, cancellation of Medicare/Medicaid payments, inability of the lab director to direct any lab for two years, and placement of the lab on the CLIA Annual Lab Registry on the CMS Web site.

EP Documents on QC in Development

In the near future, laboratorians will have an additional resource to guide their QC protocols. During the audioconference, Yost and Nichols referred to several EP documents being developed by CLSI, including Quality Management for Unit-Use Testing: Approved Guideline for Quality Control of Unit-Use Devices (EP18), which is currently undergoing revision. Both speakers indicated that the new guidance documents will provide comprehensive and flexible guidelines for quality management models that will identify potential sources of errors in unit-use test systems, starting from specimen collection through reporting of results. The recommendations will be applicable to various devices and settings and are practical to implement, so that sources of error (potential failure modes) are identified, understood, and managed.

One particularly murky issue that the new guidelines cover is the relationship between labs and manufacturers. According to Nichols, the new QC document defines user–manufacturer quality partnerships and specifies areas of responsibility via an error matrix by covering potential sources of error in the preanalytic, analytic, and postanalytic process. “For example, a manufacturer may insert a device that can check freezing or overheating during shipment. Then the lab should be responsible for checking that device every time they open up a new shipment,” Nichols explained. “If that device is broken or somehow indicates that the shipment has been degraded, they need to return that shipment and request a replacement before they implement testing. This is an example of the user–manufacturer partnership. This gets the lab thinking more about risk, the frequency of errors, what types of errors can occur, what are the consequences of those errors, and how we can decrease laboratory errors.”

In discussing the concept of QC and risk management, Nichols cited two examples and how management processes can differ with each. In a system that uses an analyzer and a reagent, the device may have many moving parts and there may be some internal checks to detect mechanical and electronic failures; however, not all parts and sources of error may be detectable by internal checks. Also, the reagent is intricately linked to the analyzer and may be susceptible to environmental effects or conditions. Two levels of control each day can detect error from many sources—the analyzer’s mechanical and electrical systems, storage and drift for the reagent, the operator, and the environment. External QC may adequately detect systematic errors that persist over time, but may fail to detect random errors that occur with single samples.

He also described the example of a device that uses a test cartridge. In such a system, most errors occur with the cartridge, while the device itself only reads the signal and may perform an electronics check, temperature check, and integrity check. In such a system, the lab director must balance the requirements for twice daily external controls against the cost and availability of alternative controls within the test system. If the manufacturer provides cartridge stability data and the lab ensures storage as recommended, what else, Nichols asked, needs to be done? Another issue to be resolved by the lab is how internal controls specific to the test lessen the risk of operator or sample errors.

Two other EP documents—Presentation of Manufacturer’s Risk Mitigation Information for Users of In Vitro Diagnostic Devices (EP22) and Laboratory Quality Control Based on Risk Management (EP23)—are under development. EP 22 will offer guidance to manufacturers about evidence needed to support QC recommendations. “There is no validated, peer-reviewed model for linking risk assessment data directly to a QC frequency. Dr. Curtis Parvin of Washington University in St. Louis and Dr. Marina Kondratovitch with the FDA are trying to develop a mathematical model to come up with figures for a frequency of external QC,” Nichols told listeners. “EP 22 has been approved in a draft format but until it’s published in its final form we won’t know exactly what it’s going to say.”

EP 23 is intended to help laboratorians develop laboratory-specific QC protocols based on manufacturer information. It will provide guidance to labs on developing effective, cost-efficient QC plans that combine the unique device, unique laboratory environment—personnel, competency, temperature, and storage—and unique clinical application to come up with a specific QC plan for that lab setting and for that device. The new guideline will also assist laboratorians in merging pertinent local regulations with manufacturer-supplied data and information about the individual laboratory into a specific QC plan. After implementation, lab directors will also want to have the ability to modify the lab’s QC protocols based on ongoing trends and events for continuous quality improvement. “Concepts being considered for this document include: How do I, as a lab director, know that the internal controls on these devices can substitute for two levels of external QC?” Nichols explained. “Will the internal controls detect environmental exposure, deviations in operator technique, and other factors with the same frequency or sensitivity as external QC? What factors did the manufacturer consider when making this recommendation and did the manufacturer place the same emphasis on certain errors that I see most frequently in my hospital and clinic settings?”

According to Yost, EP 22/23 are intended to supplement and/or replace EQC. “That’s the whole story here!” she said. “The idea to keep EQC is an interim decision that will be revisited when revised QC policies are in place. We have changed nothing regarding EQC since it was instituted in 2004.”

Advice to Lab Directors

Moving forward, Yost suggested that laboratories should follow a current, lab-director signed procedure manual for all tests. Nichols added that it’s imperative for lab personnel to keep up to date with changing regulations. “Changes are occurring based on changes in philosophy and a shift toward risk management and systems to manage quality,” he said. “It may mean less external QC and more reliance on internal device checks and error codes, but you’ll need evidence to back the decisions made in your lab to the inspectors. Remember, too, that the lab director is ultimately responsible for determining method quality and must decide comfort level with extent of validation studies, calibration, and QC procedures.”

For More Information

To obtain a CD of the AACC audioconference, “New Developments in CLIA and QC,” go to www.aacc.org and click on publications and then audioconference CDs; or call AACC Customer Service at (800) 892-1400 or (202) 857-0717.