CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
John D. Olson, MD, PhD
Brad S. Karon, MD, PhD
September 2015—When the Clinical Laboratory Improvement Amendments of 1988 were implemented in the early 1990s, a number of significant changes to proficiency testing, or PT, were required. For the 83 tests or analytes (and microbiology subspecialties) defined as CLIA regulated, the law imposed requirements on both PT providers and laboratories. Regulations require participation in at least three PT events per year (each with five specimens) for each analyte, subspecialty, or specialty (mycobacteriology requires two events per year). CLIA regulates how PT providers score PT challenges for these analytes, and mandates that all laboratories that fail to achieve satisfactory scores be reported to the Centers for Medicare and Medicaid Services and initiate corrective action for issues related to poor PT performance.
As a result of a recent CMS clarification and communication on the requirements that have to be met to resume testing after a cease-testing period, the CAP is ensuring enforcement of an additional consequence: The laboratory must cease testing for a full six months after a cease testing for a regulated analyte.
We will discuss here this consequence and how the CAP oversees PT performance for regulated analytes, but first it will be useful to define terms, as used by the CMS:
- An occurrence of PT is an event. As mentioned above, for most tests or analytes, the regulations require five specimens in three events each year. Mycobacteriology requires two events per year.
- The correct result of an individual PT sample is referred to as acceptable; an incorrect result is unacceptable.
- Failure to attain at least 80 percent (ABO, Rh, and compatibility testing require 100 percent) correct results for a regulated analyte, subspecialty, or specialty is considered unsatisfactory PT performance. Unsatisfactory PT performance due to clerical errors or data omissions is not given special consideration.
- Failure to attain at least 80 percent (ABO, Rh, and compatibility testing require 100 percent) correct results for a regulated analyte, subspecialty, or specialty for two out of three testing events is unsuccessful PT performance. The terms unsuccessful PT performance and unsuccessful PT participation are interchangeable.
Example: 2015/1 20% | 2015/2 100% | 2015/3 60%
- A subsequent unsuccessful PT performance within six or fewer PT events is called repeat unsuccessful PT performance and requires the laboratory to cease testing for that analyte, subspecialty, or specialty for six months. Note that for most analytes, six events constitute two years in a PT program. Repeat unsuccessful performance can be three consecutive failures, three out of four failures, or two sets of two out of three failures within the six events.
Example 1 (three out of four failures): 2015/1 20% | 2015/2 60% |
2015/3 100% | 2016/1 20% | 2016/2 100% | 2016/3 100%
Example 2 (two sets of two out of three): 2015/1 20% | 2015/2 60% |
2015/3 100% | 2016/1 100% | 2016/2 20% | 2016/3 0%
The CAP monitors PT performance continually. The timeframe does not stop nor does it reset annually. Thus, if a laboratory performed unsuccessfully on PT in the second or third events of 2014, or the first event of 2015, it would currently be at risk for repeat unsuccessful PT performance.
As mandated by CLIA, the CAP requires laboratories to cease patient/client testing in response to any repeat unsuccessful PT performance for a regulated analyte, specialty, or subspecialty. The PT performance of CAP-accredited laboratories is truly outstanding. In 2014, among more than 7,000 accredited laboratories (more than 1 million analyte challenges), only 23 laboratories were sent cease-testing directives for regulated analytes and no laboratory received more than one cease-testing directive. Among the analytes involved in the 2014 cease-testing directives, 16 were chemistry, four were hematology/coagulation, two were bacteriology, and one was transfusion medicine. Of note, seven cease-testing directives were for blood gas measurement, specifically pO2. This is likely related to the importance of PT specimen handling. The CAP provides information for laboratories on troubleshooting PT failures, in the Proficiency Testing Toolbox that can be found at http://j.mp/pt_troubleshooting.
The director of a laboratory that receives a cease-testing directive is required to sign an affidavit ensuring that patient/client testing has ceased for that analyte. To be reinstated, the laboratory must: