Fillable Change Of Status Form (Page 3 of 3) in pdf

INSTRUCTIONS FOR COMPLETING THE CHANGE OF STATUS FORM

Please provide only the information that is changing along with the current test menu.

Laboratory Name

This is the name that will be used for all aspects of the facility (billing, etc.). This name must be exactly the same

as it appears on your CLIA certificate. Name may only be 32 characters including spaces.

Laboratory Address

This is the physical location of the laboratory where testing and treatment is performed. Use the mailing/billing

address only if facility wants bills and other correspondence sent to separate address. Both physical and

mailing/billing address(es) must be exactly as it appears on your CLIA certificate.

Laboratory Owner

Provide the name of the person(s) or corporation that owns the laboratory.

Contact Person

Provide the name of the person to contact in the event that there are questions about the changes.

Director

This must be a person who holds a doctorate and who qualifies under Section 5.21 of the Clinical Laboratory

Regulations. The director must be the same for both State and CLIA purposes. Neither the state nor the federal

government recognizes co-directors. In order for the Department to qualify a director, a copy of the curriculum vitae

(CV), a copy of any board certifications and a copy of the director’s medical license must be enclosed. For the

Department to qualify a director as a moderate or high complexity director under CLIA, additional documents are

required. Please include a copy of any board certifications and a copy of any CEUs (continuing educational units).

Adding Tests

The following documents must be enclosed for the addition of all moderate, high complexity tests and lab-

developed tests: procedure manual, validation studies, training documentation and proof of proficiency testing

enrollment. The following documents must be enclosed for PPMP tests: list of testing personnel for PPMP tests and

documentation of Quality Assurance plan two times per year (example: proficiency testing or split samples).

Change My Certificate To

Check the appropriate type of certificate if the addition or deletion of tests will change your certificate.

Laboratory Equipment/Kits Used for Testing

List all equipment used to perform laboratory tests including glucose meters, strep test kits, etc.

ALLOW 4-6 WEEKS FOR INITIAL REVIEW

*Initial review is defined as the time the application is first reviewed for completion of required documents.

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*Laboratories closed 6 months or longer must submit a completed PA Dept. of Health Clinical Laboratory Application and

Clinical Laboratory Improvement Amendments (CLIA) application. Indicate your existing State Laboratory identification

number and Federal CLIA number on the appropriate application.

Change Of Status Form Page 3