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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Criteria for Certifying X-Ray Auditors

Subject:
Criteria for Certifying X-Ray Auditors
Area:
Program Management
Date Revised:
March, 18 1996

 

 

PURPOSE

To provide field managers with objective criteria for nominating personnel to be auditors of both State and Federal employees who conduct field tests of diagnostic x-ray equipment.

 

BACKGROUND

In 1979, the Center for Devices and Radiological Health (CDRH) initiated a program for auditing State and Federal employees conducting surveys of diagnostic x-ray equipment. Originally, thirteen auditors were selected by the Center to perform this function. The selection of these individuals was based on their long-term training in radiological health and their extensive experience in x-ray survey techniques.

Following the original selections, ORA identified and recommended to the Center the need to certify additional personnel to perform audits in order to meet workplan objectives. ORA suggested to the Center that criteria be developed to certify more individuals. The quality assurance program criteria for conducting audits of field test records and procedures and for nominating individuals for auditors was finalized and adopted in January 1980. Well qualified individuals meeting the criteria can be nominated as auditors to CDRH.

 

PROCEDURES

The criteria for qualifying "new" auditors in the field testing of diagnostic x-ray equipment consist of the following:

1. Individuals are recommended in writing by the Regional Food and Drug Director (RFDD), the Regional Radiological Health Representative (RRHR), and the individual's current auditor. The auditor's recommendation should carry the most weight as they are most familiar with the qualifications and expertise of the nominee.

2. Nominees should have completed at least the following surveys:

a. 10 Fluoroscopic

b. 10 Radiographic (general purpose)

c. 1 Mobile Radiographic

d. 1 Dental Radiographic

These field tests are required to ensure familiarity with the test procedures and calculations. Following these criteria, the auditors must closely review, for the first twenty-five field test records, the submissions of each new individual performing field tests (whether State or Federal). No hand calculations need be submitted for these field tests.

3. An examination, prepared by ORA and CDRH, must be completed by each nominee. This exam consists of five field test records to be audited with the test results calculated and classified. The results of these tests must be correctly classified, via hand calculations, and the problem data identified with possible resolutions.

The nominee must score at least 70% on the exam (i.e., the five field tests), or 481 of a possible 687 points. This shows that the nominee is able to recognize inconsistent data and make decisions as to how to test the data in light of inconsistencies. The exam can be administered and scored by the district office. Failure to pass the exam will not automatically exclude the individual from becoming an auditor.

Written recommendations, along with the need for an auditor in a specific location, and exam results, will be reviewed in making the decision on whether to designate an individual as an auditor.

The individual must be recommended in writing by the auditor, the regional radiation health representative and the district director. A formal recommendation will then be submitted by the Regional Food and Drug Director (RFDD) to CDRH, Division of Enforcement I, (HFZ-320) with an information copy to Director, Division of Emergency and Investigational (DEIO), HFC-130. CDRH will evaluate the technical competence of each candidate based on the information submitted with the recommendation, and any additional knowledge. The Center will review each submission and provide their evaluations to DEIO, who will notify the appropriate RFDD.