Proficiency Testing Review & Performance

Unsatisfactory performance is the failure to attain the minimum satisfactory score for the category or test/analyte for a testing event, including events that are failed for non-technical reasons such as late submission or failure to participate. Please note, removal of the category or test/analyte from the laboratory’s test menu, in and of itself, is not acceptable remedial action.

Laboratories receiving an unsatisfactory score are required to investigate the problem(s) that contributed to the unsatisfactory performance and implement corrective action. Laboratories may request additional test samples from their proficiency testing program provider to use as part of the remediation.

Formal notification of unsatisfactory performance will be made via email from the PT Administration Group.  The laboratory will receive an email which will indicate that a PT Document is available for review on eCLEP (available on the Health Commerce System).  The laboratory's investigation into the unsatisfactory performance must be available for review upon request. 

Unsuccessful proficiency testing performance is unsatisfactory performance for the category or test/analyte in two consecutive or two out of three consecutive testing events, including events that are failed for non-technical reasons such as a late submission or failure to participate.

CLEP notifies laboratories following unsuccessful performance via a Laboratory Evaluation Report (LER) similar to the report issued after the onsite survey process.  There are two types of LERs that can be issued: a 2-week notification or a cease testing notification. The decision as to whether the laboratory receives a 2-week notification or a cease testing notification is based on past performance, immediate jeopardy to patient care, and root cause of the unsuccessful performance.

Formal notification of unsuccessful performance will be made via email from the PT Administration Group. The laboratory will receive an email which will indicate that a PT document is ready for review and include directions to access the document using eCLEP.  Documentation of the laboratory’s investigation and the laboratory’s plan of corrective action must be submitted electronically via eCLEP within two weeks of notification of unsuccessful PT performance. CLEP may request additional information. Failure to submit an acceptable plan of correction or failure to implement the plan of correction can result in administrative action or may lead to delays in issuing the laboratory permit.

Please note, removal of the category or test/analyte from the laboratory’s test menu, in and of itself, is not acceptable remedial action. Remediation programs should be designed based on the nature of the unsatisfactory performances and the area of clinical laboratory medicine involved.

2-week notification

The laboratory must:

• investigate and document the problem(s) that contributed to the unsuccessful performance and implement corrective action,
• conduct a retrospective review of patient results to ascertain whether similar error(s) existed in reports of test findings and notify the ordering physician if necessary, and
• reply to the LER within 2 weeks.

The laboratory's remediation must be acceptable to CLEP.  If effective corrective action is not implemented and documented to the satisfaction of the proficiency testing technical section, the laboratory will be required to cease testing clinical specimens.

Cease testing notification

The laboratory must:

• cease testing for the analyte(s) involved in the unsuccessful performance
• identify the permitted laboratory where patient specimens will be sent for such testing
• investigate and document the problem(s) that contributed to the unsuccessful performance and implement corrective action,
• conduct a retrospective review of patient results to ascertain whether similar error(s) existed in reports of test findings and notify the ordering physician if necessary, and
• reply to the LER within 2 weeks.

The laboratory's remediation must be acceptable to CLEP.

Laboratories issued a directive to cease testing clinical specimens due to unsuccessful PT performance will be reinstated after:

• documentation of corrective action has been determined to be acceptable,
• the laboratory demonstrates satisfactory performance in two consecutive test events obtained from the same proficiency test provider (one may be an off-cycle event), and
• at least six months has elapsed since the cease testing order.

Subsequent unsuccessful proficiency testing performance is defined as unsatisfactory PT performance for the category or test/analyte (NYS mandated PT analytes) in 3 out of 5 consecutive testing events. 

Laboratories demonstrating a subsequent unsuccessful PT performance will be instructed to cease testing clinical specimens.

Formal notification of subsequent unsuccessful performance will be made via email from the PT Administration Group. The laboratory will receive an email which will indicate that a PT document is ready for review and include directions to access the document using eCLEP.  Documentation of the laboratory’s investigation and the laboratory’s plan of corrective action must be submitted electronically via eCLEP within two weeks of notification of unsuccessful PT performance. CLEP may request additional information. Failure to submit an acceptable plan of correction or failure to implement the plan of correction can result in administrative action or may lead to delays in issuing the laboratory permit.

Laboratories issued a directive to cease testing clinical specimens due to subsequent unsuccessful PT performance will be reinstated after:

• documentation of corrective action has been determined to be acceptable,
• the laboratory demonstrates satisfactory performance in two consecutive test events obtained from the same proficiency test provider (one may be an off-cycle event), and
• at least six months has elapsed since the cease testing order.

Where performance in PT provides evidence of risk for patient harm as determined by the NYS Proficiency Testing Clinical Standard of Practice, and the laboratory does not cease testing as directed, the Department will take enforcement action as authorized by Sections 576(3) and 577 of New York State Public Health Law, Article 5, Title V.

Unacceptable performance is the failure to attain the minimum satisfactory score (80%) for the category or test/analyte (non-NYS mandated PT analytes) for a testing event, including events that are failed for non-technical reasons such as late submission or failure to participate. Laboratories receiving an unacceptable score are required to investigate the problem(s) that contributed to the unacceptable performance and implement corrective action. Laboratories may request additional test samples from their PT provider to use as part of the remediation.

Formal notification of unacceptable performance will be made via email from the PT Administration Group. The laboratory will receive an email which will indicate that a PT document is ready for review and include directions to access the document using eCLEP.  The laboratory’s investigation into the unacceptable performance must be available for review upon request.

Repeat unacceptable performance is the failure to attain the minimum satisfactory score (80%) for the category or test/analyte (non-NYS mandated PT) for 2 out of 3 consecutive testing events, including events that are failed for non-technical reasons such as late submission or failure to participate. Laboratories receiving a repeat unacceptable score are required to investigate the problem(s) that contributed to the unacceptable performance and implement corrective action. Laboratories may request additional test samples from their proficiency testing provider to use as part of the remediation.

Formal notification of repeat unacceptable performance will be made via email from the PT Administration Group. The laboratory will receive an email which will indicate that a PT document is ready for review and include directions to access the document using eCLEP. Documentation of the laboratory’s investigation and the laboratory’s plan of corrective action must be submitted electronically via eCLEP within two weeks of notification of repeat unacceptable PT performance. CLEP may request additional information. Failure to submit an acceptable plan of correction or failure to implement the plan of correction can result in administrative action or may lead to delays in issuing the laboratory permit.

Unsuccessful proficiency testing performance is defined as unacceptable PT performance for the category or test/analyte (non-NYS mandated PT analytes) in 3 out of 5 consecutive testing events.

CLEP notifies laboratories following unsuccessful performance via a Laboratory Evaluation Report (LER) similar to the report issued after the onsite survey process.  There are two types of LERs that can be issued: a 2-week notification or a cease testing notification. The decision as to whether the laboratory receives a 2-week notification or a cease testing notification is based on past performance, immediate jeopardy to patient care, root cause of the unsuccessful performance.

Formal notification of unsuccessful performance will be made via email from the PT Administration Group. The laboratory will receive an email which will indicate that a PT document is ready for review and include directions to access the document using eCLEP. Documentation of the laboratory’s investigation and the laboratory’s plan of corrective action must be submitted electronically via eCLEP within two weeks of notification of unsuccessful PT performance. CLEP may request additional information. Failure to submit an acceptable plan of correction or failure to implement the plan of correction can result in administrative action or may lead to delays in issuing the laboratory permit.

Please note, removal of the category or test/analyte from the laboratory’s test menu, in and of itself, is not acceptable remedial action. Remediation programs should be designed based on the nature of the unacceptable performances and the area of clinical laboratory medicine involved.

2-week notification

The laboratory must:

• investigate and document the problem(s) that contributed to the unsuccessful performance and implement corrective action,
• conduct a retrospective review of patient results to ascertain whether similar error(s) existed in reports of test findings and notify the ordering physician if necessary, and
• reply to the LER within 2 weeks.

The laboratory's remediation must be acceptable to CLEP.  If effective corrective action is not implemented and documented to the satisfaction of the proficiency testing technical section, the laboratory will be required to cease testing clinical specimens

Cease testing notification

The laboratory must:

• cease testing for the analyte(s) involved in the unsuccessful performance,
• identify the permitted laboratory where patient specimens will be sent for such testing,
• investigate and document the problem(s) that contributed to the unsuccessful performance and implement corrective action,
• conduct a retrospective review of patient results to ascertain whether similar error(s) existed in reports of test findings and notify the ordering physician if necessary, and
• reply to the LER within 2 weeks.

The laboratory's remediation must be acceptable to CLEP.

Laboratories issued a directive to cease testing clinical specimens due to unsuccessful PT performance will be reinstated after:

• documentation of corrective action has been determined to be acceptable,
• the laboratory demonstrates satisfactory performance in two consecutive test events obtained from the same proficiency test provider (one may be an off-cycle event), and
• at least six months has elapsed since the cease testing order.

Subsequent unsuccessful PT performance is defined as unacceptable PT performance for the category or test/analyte (non-NYS mandated PT analytes) in 4 out of 5 consecutive testing events.

Laboratories demonstrating a subsequent unsuccessful PT performance will be instructed to cease testing clinical specimens.

Formal notification of repeat unsuccessful performance will be made via email from the PT Administration Group. The laboratory will receive an email which will indicate that a PT document is ready for review and include directions to access the document using eCLEP. Documentation of the laboratory’s investigation and the laboratory’s plan of corrective action must be submitted electronically via eCLEP within two weeks of notification of subsequent unsuccessful PT performance. CLEP may request additional information. Failure to submit an acceptable plan of correction or failure to implement the plan of correction can result in administrative action or may lead to delays in issuing the laboratory permit.

Laboratories issued a directive to cease testing clinical specimens due to subsequent unsuccessful PT performance will be reinstated after:

• documentation of corrective action has been determined to be acceptable,
• the laboratory demonstrates satisfactory performance in two consecutive test events obtained from the same proficiency test provider (one may be an off-cycle event), and
• at least six months has elapsed since the cease testing order.

Where performance in PT provides evidence of risk for patient harm as determined by the NYS Proficiency Testing Clinical Standard of Practice, and the laboratory does not cease testing as directed, the Department will take enforcement action as authorized by Sections 576(3) and 577 of New York State Public Health Law, Article 5, Title V.