The Department will review each laboratory’s results for all graded proficiency testing surveys. The CMS-approved providers will release results and enrollment information to the Department for review. Unsatisfactory or unsuccessful performance in any proficiency testing event may lead to sanctions as described below. Laboratories may be required to submit documentation, including descriptions of investigation and corrective action, following unsatisfactory or unsuccessful 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 that are applying for permit in a category or are approved for a category 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. A summary of the investigation and corrective actions must be submitted to the Department for review when requested; the Department may request additional information. 

The documentation of the investigation and the laboratory's plan of correction must be submitted electronically [2] within 2 weeks of receipt of evaluation report indicating the unsatisfactory performance. Failure to submit an acceptable plan of correction or failure to implement the plan of correction can result in administrative action and may lead to delays in issuing the laboratory permit.

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. The Department notifies laboratories following unsuccessful performance via a Laboratory Evaluation Report (LER) similar to the survey process [3]. 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 are required to investigate and document the problem(s) that contributed to the unsuccessful performance and implement corrective action. The findings of the laboratory investigation and a description of the corrective action that is implemented must be submitted to the Department as part of the Plan of Correction to the Laboratory Evaluation Report.

Remediation programs are designed based on the nature of the unsatisfactory performances and the area of clinical laboratory medicine involved. An on-site inspection of the laboratory may be conducted. Once the laboratory's remediation is acceptable to the Department, the laboratory must demonstrate satisfactory performance in two consecutive proficiency test events.

The decision as to whether a laboratory should be ordered to cease testing of clinical specimens upon a first unsuccessful performance in proficiency testing is based on responses to the following questions: (see Proficiency Testing Sustaining Standard of Practice 11 (PT S11): Unsuccessful Performance – Cessation of Patient Testing [4] in the Clinical Laboratory Standards of Practice)

1. Are the analytical errors suggestive of immediate jeopardy to patient care?
2. Has the laboratory demonstrated an inability to make progress toward improvement of previously identified substandard performance following a reasonable opportunity to correct deficiencies?
3. Are the root causes of substandard performance systemic to laboratory practices?
4. Has the laboratory demonstrated a history of non-compliance with standards of good laboratory practice?
5. Have there been other instances of unsuccessful performance in the category within the past two years that reflect a pattern of poor performance relevant to the current event?

If the response is yes to any one of the questions 1 - 5 above and the validity of the proficiency event is substantiated, the Department is obligated to instruct the laboratory to cease testing clinical specimens and to require the laboratory to perform the following:

1. Identify the permit laboratory to which it will refer clinical specimens;
2. Investigate the cause(s) of substandard performance in the proficiency program; and
3. Conduct a retrospective review of patient results to ascertain whether similar error(s) existed in reports of test findings and to assess the need for notification of the ordering physician.

Laboratories that comply with a directive to cease testing clinical specimens due to a first unsuccessful proficiency testing 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, and at least six months has elapsed since the cease testing order.

Where performance in proficiency testing provides evidence of risk for patient harm and the laboratory does not cease testing as directed, the Department will take enforcement action as authorized by Sections 576(3) and 577 of Public Health Law, Article 5, Title V.

If the response to each of questions 1 - 5 above is no, and if the director responsible for the category where the proficiency testing failure occurred determines that the cause(s) of the substandard performance is not systemic, can be remedied in a timely manner, and the level of performance does not compromise the clinical utility of results, the laboratory is allowed to continue testing of clinical specimens as test performance is investigated and monitored.

The laboratory will be notified of the unsuccessful performance in proficiency and be instructed to perform the following:

1. Investigate immediately the cause(s) of substandard performance;
2. Report its findings to Clinical Laboratory Evaluation Program within two weeks (ten business days) of notification of unsuccessful performance; and
3. Demonstrate the effectiveness of corrective action by successful performance in two consecutive proficiency testing events, only one of which can be an off-schedule event.  Please note that the off-schedule must be from the same proficiency testing provider as the regularly scheduled proficiency testing event.

The documentation of cause(s) of unsuccessful performance and the effectiveness of corrective action must be provided to the Program within two weeks (10 business days) of notification of unsuccessful performance. If effective corrective action is not implemented and documented to the satisfaction of the Department, the laboratory will be required to cease testing clinical specimens.

 

The laboratory must characterize the cause(s) of substandard performance, develop and implement a plan of corrective action, and substantiate the effectiveness of corrective action by successful performance in two consecutive proficiency test events. As a CLIA-exempt state, the Department must notify the federal Centers for Medicare and Medicaid Services (CMS) of any sanctions (e.g., orders to cease testing of clinical specimens) brought against laboratories enrolled in any proficiency testing program.

Laboratories demonstrating a subsequent unsuccessful (three consecutive unsatisfactory performance or three unsatisfactory performances in four or five consecutive test events) will be instructed to cease testing clinical specimens. Laboratories that comply with a directive to cease testing clinical specimens due to subsequent unsuccessful proficiency testing 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, and at least six months has elapsed since the cease testing order.

Where performance in proficiency testing provides evidence of risk for patient harm as determined by criteria a-e under Proficiency Testing Sustaining Standard of Practice 11 (PT S11): Unsuccessful Performance – Cessation of Patient Testing [5], and the laboratory does not cease testing as directed, the Department will take enforcement action as authorized by Sections 576(3) and 577 of Public Health Law, Article 5, Title V [6].