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Certificate of Qualification & Laboratory Director Requirements

As required in New York State Public Health Law, all individuals designated as laboratory directors or assistant directors at a clinical laboratory or blood bank holding or applying for a New York State clinical laboratory permit must hold a Certificate of Qualification in the required category(ies).

If the individual designated as the laboratory director does not qualify for a Certificate of Qualification in each permit category, the director may designate one or more individuals who hold a Certificate in the required category(ies) to serve as director for the category(ies).

Temporary absences of the laboratory director, or sole certificate holder for a category, of greater than or equal to three weeks must be reported to the Program and an individual with a Certificate of Qualification in the appropriate category(ies) must be identified to provide coverage in the director’s absence.

Duties and Responsibilities

The eligibility of a laboratory to obtain approval to perform testing is dependent on the scope of the laboratory director’s Certificate of Qualification. Laboratory directors and assistant directors must indicate the actual hours they will serve on-site, and the adequacy of these hours will be evaluated commensurate with the laboratory workload, scope and complexity of test procedures, qualifications of on-site personnel, and availability of alternate monitoring and communication capabilities.

An individual may serve as director or sole certificate holder (a.k.a., sole director) for a permit category for no more than two clinical laboratories and/or blood banks. If the laboratory and blood bank are located on the same premises, this may be considered as one directorship. Assistant Directorships (provided the individual is not the sole certificate holder for a permit category) and directorships of Limited Service Laboratories are not included in the two-site limit

Obtaining a Certificate of Qualification

The initial application fee is $40.00. Applicants must document an acceptable combination of education, training, and experience to qualify for a certificate including at least four years of postdoctoral training and/or experience in an acceptable laboratory of which two or more years of training and/or experience must be demonstrated in the methods and techniques currently in use in the permit category(ies) sought and two or more years of experience in general laboratory management. A portion of this training and/or experience must have been obtained within the previous six years. For some categories, a questionnaire is provided:

Applicants are required to indicate all appropriate board certifications (from a list included in the instructions), certification date and specialty, and provide a copy of each certificate and any re-certifications with their application.

Since a Certificate of Qualification is issued to an individual independent of laboratory affiliation, the home address of the applicant is used. Correspondence regarding the Certificate of Qualification is primarily directed to the applicant's email address. It is the responsibility of the Certificate holder to notify the program of changes in the information provided in the application, to include changes in physical and email address.

A Certificate of Qualification is valid for two years from the date it is issued and an application to renew must be submitted every two years. Additional Certificate categories may be requested using the Amend Certificate of Qualification Form. Instructions are provided. Documentation of experience is required and should be submitted with the application.

Education Requirements

The minimum education required to obtain a Certificate of Qualification is an M.D., D.O., or D.D.S. degree, or an earned doctoral degree (e.g., Ph.D., Sc.D.) in a relevant chemical, physical, or biological science major from an accredited institution. All medical schools, colleges and universities attended must be indicated in the application.

Physicians and dentists must be currently registered in New York State and/or the state in which they practice, and must provide a copy of their license and current registration. Unlicensed physicians or dentists do not qualify for a Certificate of Qualification.

For individuals educated in a college or university located outside the United States, a credentials equivalency evaluation by an approved agency is required. The Department will accept credential equivalency evaluations from any of the organizations listed as members of the National Association of Credential Evaluation Services or the Association of International Credential Evaluators, Inc. Evaluations are valid only if received in a sealed envelope or directly from the evaluating agency.

Training and Experience

Applicants for a Certificate of Qualification must provide a summary of their post-doctoral training and experience and current employment, including a detailed description of their laboratory duties and the areas of laboratory medicine in which their experience has been gained. All post-doctoral clinical laboratory experience should be included. A copy of the current curriculum vitae must also be submitted.

Physicians must document the specific dates and disciplines of each rotation performed during residency and/or fellowship. Applicants whose residency and/or fellowship occurred more than six years ago, or those who are applying for categories for which education and laboratory experience are the only requirements, must provide documentation of their experience in the form of one or more letters from a current or previous laboratory director or other individual with whom the post-degree training and/or experience was acquired or from a recognized expert in the categories requested.

Each letter should provide specific details about the dates of employment, type of training and experience acquired, methods and techniques of test procedures used, and volume of testing personally performed, supervised, and/or directed. Letters from responsible administrators at institutions where training or experience was acquired will be accepted only where it is established that other references are not available. Self-attestations of experience and training are not acceptable.

Maintaining Certificate of Qualification

Approximately four months before the Certificate of Qualification expires, the certificate holder is sent a pre-printed reapplication to the home address on file with the department. This application must be completed and returned along with the $40.00 reapplication fee and a copy of the applicant's current curriculum vitae no later than 90 days prior to expiration.

In order to maintain a Certificate of Qualification, the applicant must demonstrate recent training and/or experience in each category currently held. If the applicant has not been assigned responsibility for a related clinical laboratory permit category at a New York State permitted laboratory, or is not listed as the director of record at a non-New York State permitted laboratory with the appropriate specialty in the CLIA database, he/she must provide documentation of experience in the form of one or more letters from a current or previous laboratory director or other individual with whom the post-degree training and/or experience was acquired. Each letter should provide specific details about the dates of employment, type of training and experience acquired, methods and techniques of test procedures used, and volume of testing personally performed, supervised, and/or directed. Self-attestations of experience and training are not acceptable.