Clinical Laboratory Evaluation Program The Clinical Laboratory Evaluation Program Thec Clini al Laboratory

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  • Application Procedures • Personnel Requirements

    Laboratory Surveys • Proficiency Testing

    Revised March 2015

    Clinical Laboratory Evaluation Program

    A Guide to Program Requirements and

    Services

  • Clinical Laboratory Evaluation Program Guide March 2015 NYS DOH Wadsworth Center

    Table of Contents INTRODUCTION ............................................................................................................................................................................................... 3

    The Clinical Laboratory Reference System .............................................................................................................................................. 3 The Clinical Laboratory Evaluation Program ............................................................................................................................................ 3

    PERMIT REQUIREMENTS ............................................................................................................................................................................... 4 Program Scope and Exceptions ............................................................................................................................................................... 4 Application Procedures ............................................................................................................................................................................ 4 Health Commerce System ...................................................................................................................................................................... 4 Proficiency Testing .................................................................................................................................................................................. 5 Test Approval .......................................................................................................................................................................................... 5 On-Site Survey ........................................................................................................................................................................................ 5 Issuing the Laboratory Permit ................................................................................................................................................................. 7 Changes in Laboratory Status .................................................................................................................................................................. 7 Adding or Deleting Permit Categories or Tests/Analytes .......................................................................................................................... 7 Permit Reapplication ................................................................................................................................................................................ 8 Laboratory Inspection and Reference Fees ............................................................................................................................................. 8

    LABORATORY DIRECTOR REQUIREMENTS ................................................................................................................................................ 9 Duties and Qualifications ......................................................................................................................................................................... 9 Applying for a Certificate of Qualification ................................................................................................................................................ 9 Education Requirements .......................................................................................................................................................................... 9 Foreign Education ................................................................................................................................................................................... 9 Board Certification ................................................................................................................................................................................... 9 Training and Experience ........................................................................................................................................................................ 10 Issuing the Certificate of Qualification .................................................................................................................................................... 10 Maintenance of the Certificate of Qualification ....................................................................................................................................... 10

    LABORATORY TESTING PERSONNEL REQUIREMENTS ............................................................................................................................ 11 The Clinical Laboratory Technology Practice Act ................................................................................................................................... 11 Duties and Qualifications of Laboratory Personnel ............................................................................................................................... 11 Evaluating Laboratory Personnel ........................................................................................................................................................... 11 Foreign Education.................................................................................................................................................................................. 11 Training and Experience ........................................................................................................................................................................ 12 Personnel Record Retention Requirements ........................................................................................................................................... 12

    PROFICIENCY TESTING PROGRAMS .......................................................................................................................................................... 13 Documenting the Proficiency Testing Process ..................................................................................................................................... 13 Proficiency Testing Frequency .............................................................................................................................................................. 13 Requirements for Participation .............................................................................................................................................................. 14 Ungradeable Proficiency Testing Samples ............................................................................................................................................. 14 Proficiency Testing Program Administrative Policies ............................................................................................................................ 14

    PROFICIENCY TESTING EVENT FAILURES ............................................................................................................................................... 16 Unsatisfactory Proficiency Testing Performance .................................................................................................................................. 16 Unsuccessful Proficiency Testing Performance ................................................................................................................................... 16 Reinstatement after Unsuccessful Performance .................................................................................................................................. 17 Subsequent Unsuccessful Proficiency Testing Performance ............................................................................................................... 17

    ADDITIONAL APPLICATION REQUIREMENTS ........................................................................................................................................... 18 Limited Service Laboratories ................................................................................................................................................................ 18 Limited Transfusion Service .................................................................................................................................................................. 18 Health Fairs........................................................................................................................................................................................... 18 Patient Service Centers ......................................................................................................................................................................... 19 Direct Access Testing ............................................................................................................................................................................ 19

    QUESTIONS ................................................................................................................................................................................................... 20 COMPLAINTS/CONCERNS ..............................................................................................................................