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PT surveys: monitoring corrective action.

A simple form can help you turn PT failures into valuable opportunities to demonstrate responsiveness.

ACCORDING TO the dictates of CLIA '88, not only must clinical labs enroll in an approved proficiency testing (PT) program, they must also participate successfully. Failure to succeed at PT can result in sanctions up to and including suspension of the lab's CLIA certificate and forfeiture of Medicare payments for the specialty, subspecialty, or analyte involved.

If your certificate is suspended or your Medicare approval is terminated, you must demonstrate sustained successful performance on two consecutive PT events before being considered for reinstatement. You must also take appropriate action to correct the problem and prevent recurrence. And, of course, all such action must be documented.

* Mechanism for monitoring. Under CLIA's quality assurance standards, a lab needs an ongoing mechanism to monitor corrective actions taken for any unacceptable, unsatisfactory, or unsuccessful PT result. It therefore is essential to establish comprehensive, written remedial programs that are easy to understand. Documentation of corrective actions shows inspectors that appropriate measures are carried out when a deficiency is detected through a PT failure.

As the lab QA coordinator at Anderson Area Medical Center, a 587-bed, not-for-profit hospital in Anderson, S.C., my job was to create a written policy and procedure for handling results from our PT programs. Our medical director and other administrators felt that, to stay in compliance with CLIA, an organized approach to reviewing proficiency testing scores and insuring the timely receipt and return of PT challenges was needed. In this way, we hoped to prevent careless mistakes that could lead to sanctions or license suspensions. * Oversight. In September 1992, we formed our proficiency testing review (PTR) committee to address issues of PT follow-up. Members of the committee included the medical director, administrative director, three lab managers, and myself.

The group's mission is to:

* Review all PT survey reports.

* Discuss and review corrective action.

* Check for appropriate signatures.

* Watch for trends in unsuccessful events and unsatisfactory surveys.

* Monitor compliance with regulatory standards.

We designed a form to assist our laboratory section supervisors when reporting a PT failure to the PTR committee. The two-sided form has been successful for us since we began using it in January 1993. Following is a summary of its components:

Section I. We clearly identify the PT event in question. In the fictitious example shown, the failure occurred after a refrigerator malfunction spoiled a CAP survey for comprehensive coagulation.

Section II. We identify and categorize deficiency types using a master list of codes derived from the CAP Q-Probe program.|1~

Eventually we will computerize our trend tracking so as to better follow up on PT failures (most of them in non-regulated testing).

Section III. There are eight fundamental steps that serve as a checklist for our supervisors in systematically navigating a PT-failure investigation.

In documenting the review, investigators circle "yes" or "no" to each step. There is additional space for comments on the reverse side.

In the example, an investigator wrote "QNS" next to step five to indicate that not enough viable PT material remained to rerun the test.

Section IV. We use this part for a concise statement that documents what corrective action was taken.

Section V. This section is used to document that the corrective action was effective. We encourage additional, supportive documentation.

Section VI. Here we verify that we reviewed the problem with the personnel involved in the PT failure and implemented corrective actions designed to prevent recurrence. We believe that adequate communication of problems and changes is essential to the improvement process.

The back of the form has ample space for comments and staff signatures. Members of the PTR committee--usually myself and the medical director--date and sign the form to attest to our participation in the PT review process.

* Testing suspended. The PTR committee meets on an as-needed basis--as soon as possible after a PT failure score is received (allowing adequate time, usually 2 or 3 days, for supervisory investigation).

PT challenge failure investigations are taken seriously. Patient testing is suspended and the problem assay is sent out until proficiency can be proved. Such a hiatus is both inconvenient and costly.

* Avoiding errors. The close monitoring of PT scores and the elimination of careless errors and preventable mistakes has never been more essential. In light of CLIA's several and painful penalties, we all must pay increased attention to documenting improvement efforts. We must design and implement clear-cut policies and procedures, and use standardized follow-up forms, such as that shown in Figure 1, to insure timely reviews of identified problems.

Through such systematic problem solving we can help our laboratories to meet regulatory standards for proficiency testing as well as to provide better service to all those who are dependent on us for accurate test results.


1. Howanitz PJ, Renner SW, Sarewitz SJ. Laboratory Proficiency Testing. Q-Probe 92-08. Northfield, Ill: CAP; 1992.

Elizabeth Ann Nichter, M.S., MT(ASCP), CLN(NCA) is laboratory quality assurance coordinator at Anderson Area Medical Center, Anderson, S.C.
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Title Annotation:proficiency testing program
Author:Nichter, Elizabeth Ann
Publication:Medical Laboratory Observer
Date:Jan 1, 1994
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