Ronald D. Feld, Ph.D., Marian Schwabbauer, Ph.D., CLDir(NCA)*, John D. Olson, M.D., Ph.D.
Upon completion of this section, the reader should be able to:
1)Describe which tests require proficiency testing (PT) and list three sources of approved PT samples.
2)Explain the rules regarding the analysis of PT samples.
3)Given a scenario, correctly identify as successful or unsuccessful PT testing and describe the remedial action that should be implemented after unsuccessful PT participation.
4)Design a system for keeping PT testing records.
5)Describe the sanctions and appeals process that may accompany the inspection and/or PT processes.
Proficiency Testing
Proficiency testing (PT) is one of the main methods besides
inspection whereby HCFA will decide on the quality of a particular
laboratory. The regulations for proficiency testing appear in Subpart
H. HCFA certifies various agencies to
offer proficiency testing programs on its behalf. This is referred to
as deemed status. An approved PT program has been evaluated by HCFA
and is in compliance with the requirements of Subpart I.
Proficiency testing is required for moderate and high complexity tests but not for waived tests. The laboratory must enroll in an approved PT testing program that covers each non-waived test. If the laboratory performs an analyte for which no approved PT testing is available, it must demonstrate the accuracy of this analyte at least twice a year (covered under quality assurance).
A laboratory which performs testing at multiple sites but is covered under a single certificate must enroll in a PT program for the collective tests under that license. A laboratory which performs the same analyte by multiple methods must only submit PT for one of the methods. The method chosen may not be the one used to perform the highest number of patient samples. As long as some patient samples are performed by that method, it may be chosen as the site for PT testing. However, if the laboratory fails the proficiency test, it may be required to stop performing that analyte by all methods.
If a laboratory with a single certificate performs the same assay at different sites, PT must be performed by the primary method or if there are multiple sites with the primary method, PT can be alternated by site. Failure of PT could lead to the revocation of testing at all sites covered under a single certificate.
The laboratory must notify HCFA which approved PT program or programs it has chosen. Sometimes multiple programs may be necessary to cover all the analytes performed. In the event a laboratory has multiple PT programs that cover the same analytes, it must notify the program which challenge should be sent to HCFA to comply with CLIA regulations. It is important that a laboratory designates only one PT program per analyte. If the laboratory wishes, they may analyze PT samples for which they will not return values. In fact, since the results for all the analytes in a PT program for which you paid will be returned to you for review, it is a good form of external QC.
A laboratory may change PT programs only once a year and the laboratory must notify HCFA before any change. If a laboratory adds a specialty or subspecialty that was not in the original application for certification that is not covered in the existing PT program, it may change PT programs at the next enrollment period.
Analyzing Proficiency Testing Samples
The regulations are very specific about the analysis
of PT samples. The inspector will look carefully to make sure
that PT samples are handled in the same exact manner as patient
samples. This must be attested to by the laboratory director and the person performing the analysis.
Procedures that are forbidden include:
The laboratory must document every step in the proficiency testing process. This includes receipt, preparation, and each step in the testing and reporting of PT results. Records of PT testing include report forms used to record results as well as attestation from the director and analyst that the samples were handled exactly as patient samples. These records must be kept for a period of two years from the PT event.
Successful PT Participation
In Subpart I of the Feb. 28, 1992 regulations, HCFA delineates the
acceptable limits for PT testing for regulated
analytes. Except in the case of bacteriology, mycobacteriology,
mycology, parasitology, and virology where PT testing depends on the
presence of certain organisms, most of the other regulated analytes'
performance is based on a target value and a published acceptable
limit around that target value.
The target value is determined by the mean of an appropriate peer group. A peer group consists of laboratories which perform an assay with like reagents and instrumentation. A peer group must contain at least 10 laboratories that use similar systems. If you utilize a method that does not have a peer group, you may be compared to the all method mean. This may be determined by using the mean of labs using a particular reagent regardless of instrument. It is obviously advantageous to choose reagents and instruments for which a peer group exists. The all method mean reflects the biases which may be present in the methods which dominate that category.
In some cases, the survey organization may choose laboratories who use the accepted reference method as the target value group. For instance, the College of American Pathologists (CAP) uses the glucose oxidase method to set the target value for all glucose methods. If there is not a consensus of 90% of the referee laboratories for an analyte, the PT for that analyte will not be graded. The Clinical Laboratory Improvement Advisory Committee (CLIAC) has recently suggested that the referee laboratory consensus be lowered to 80%. This would result in an increase in the gradable PT challenges.
Grading Proficiency Testing
The requirements for PT state that for each regulated analyte, there
must be at least three yearly challenges consisting of five samples each for a total of 15 yearly samples per analyte. Most PT
samples for quantitative analytes are received in a lyophilized form.
It is critical that reconstitution instructions are followed
precisely. Well calibrated pipettes and reagent grade water, if no
diluent is supplied, should be used to reconstitute the sample and
are critical to good PT results. Some samples require time to
dissolve after reconstitution and before analysis. Analysis should
occur on the same day as reconstitution in case any of the analytes
have limited stability. The PT samples should be refrigerated when
not undergoing analysis. Any unused portion of the PT sample should
be frozen in case there is a PT failure and troubleshooting of the
analysis is necessary.
The rule of 80% applies to most PT grading. A laboratory must score at least 80% (four out of five samples within the allotted limits) in order to be within compliance. Failure to score 80% on one or more analytes in a given challenge is labeled unsatisfactory performance. Unsatisfactory performance can also occur if the laboratory fails to participate in a PT program for an analyte that is performed. This assumes that there is a PT program available for that analyte. Unsatisfactory performance can also occur by failing to return the PT results within the time frame specified by the program. Be especially careful in filling out the PT report form as clerical errors are counted as failures.
A laboratory showing unsatisfactory performance on a single PT event is not subject to sanctions but must show remedial action to correct the problem. Steps that might be used in correcting the problem are: a) check for clerical errors, b) check the quality control for the date the PT samples were run, c) check the calibration schedule to determine how close to the PT samples calibration was performed, d) determine when calibration verification was performed with respect to the PT samples, e) check equipment logs for maintenance performed, and f) rerun frozen PT sample. Once the problem(s) that caused PT failure is found, it should be rectified, documented, and reviewed with the laboratory staff. Unsuccessful participation occurs when there is an unsatisfactory performance for the same analyte on two consecutive or two out of three consecutive PT challenges. At this point, sanctions can be imposed on the laboratory.
Sanctions and
Appeals
Sanctions and appeals are discussed in Subpart R of the Feb. 28, 1992
regulations. Sanctions can be imposed for deficiencies found during
inspections or for unsuccessful participation in proficiency testing.
There are two kinds of sanctions which may be imposed by the HCFA. Principal sanctions involve the suspension, limitation, or revocation of the CLIA certificate. Alternate sanctions are lesser penalties and include development of a correction plan, on-site monitoring, and/or civil money penalties.
There are a number of factors which HCFA may consider before imposing sanctions. These include: whether the deficiencies pose immediate danger; the nature, severity and duration of the deficiencies; whether the deficiencies have been repeatedly cited; the accuracy and extent of records pertaining to the noncompliance and their availability; the relationship of deficiencies to each other; the compliance history of the laboratory; the outcome that is desired by imposing sanctions; the corrective response of the laboratory to deficiencies; and the recommendation of appropriate state agencies. A separate sanction may be applied for each deficiency or a single sanction for a number of deficiencies.
Originally, the sanctions outlined by HCFA for unsuccessful PT performance under CLIA were quite punitive, including loss of the ability to perform an analyte or entire subspecialty. Later HCFA announced that its policy for remedying unsuccessful PT performance would emphasize training and education over sanctions. If the unsuccessful PT performance is deemed to be beyond the laboratory's control by the CLIA surveyor, no sanction will apply. If, however, it is determined to be within the laboratory's control, the surveyor should recommend solutions to the laboratory and obtain a plan of correction that can be verified. More punitive sanctions can be applied if the surveyor determines there is immediate jeopardy to patient health, the laboratory refuses to correct the problem or has a history of compliance problems in the same area, or if there are repeated episodes of PT failure.
If a condition level noncompliance is identified, HCFA must give written notice to the laboratory which includes: the noncompliance identified, proposed sanctions, rationale for sanctions, effective date and duration of sanctions, the authority for the sanctions, and time allowed for the laboratory to respond. The laboratory must have at least ten days to respond.
The laboratory may submit to HCFA written evidence or other information in its defense. HCFA must provide written acknowledgment of the laboratory's evidence and whether the sanctions will still be imposed. There must be at least five days before imposing sanctions if there is immediate jeopardy and 15 days if there is not.
If the laboratory is still not satisfied with the sanction, it is entitled to a hearing before an Administrative Law Judge and has 60 days from the sanction notice to request a hearing. If dissatisfied with the hearing decision, the laboratory may request a review by the Departmental Appeals Board.
An alternative route of appeal is to file with the U.S. Court of Appeals in the circuit where the laboratory has its principal place of business. This appeal must be filed within 60 days after the decision to impose civil money penalties, suspension, revocation, or limitation of the CLIA certificate becomes final.
Those laboratories that participate in Medicare may also receive suspension of their Medicare payments as a sanction. This may be for the entire laboratory services or for single analytes or groups of analytes.
Proficiency Testing (PT)
If you are performing testing for any of the analytes or tests
listed below, you must be enrolled in PT for those analytes or
tests:
Hematology
Diagnostic Immunology
General Immunology
Chemistry
Routine Chemistry
Chemistry
Endocrinology
Chemistry
Toxicology
Immunohematology
Microbiology
Note: You must be enrolled in PT for the full extent of testing being performed (cgs, gram stain, acid fast stain, wet mount, primary inoculation, direct antigen testing, isolation, identification and susceptibility).
Ronald D. Feld, Ph.D., Marian Schwabbauer, Ph.D., CLDir(NCA), John D. Olson, M.D., Ph.D.
Peer Review Status: Internally Peer
Reviewed