Printable Maryland State Compliance Application Template

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Maryland Department of Health and Mental Hygiene

Office of Health Care Quality – Laboratory Licensing Programs

Spring Grove Center – Bland Bryant Building

55 Wade Avenue, Catonsville, MD 21228

Phone: 410.402.8025 Fax: 410.402.8213

State Compliance Application

I. Laboratory Information

II. Director Information

Certification by American Specialty Board (Name, Date, Number)

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VI. Mandatory, You Must List Testing Instrumentation and Test Kits Used in the Laboratory

***Please also include test discipline/subdicipline (e.g. Chemistry-Routine) if using Schedule A***

VII. Proficiency Testing

VIII. Ownership Information

A. Type of Entity

Other (Specify) _____________________________________

B.This section is MANDATORY, application will be returned if left blank. Social Security Number is unacceptable

IX. Attestation

I certify that the information provided in this application is true and complete, understanding that any knowing and willful false statement or representation, or failure to fully and accurately disclose the requested information in this application, may be prosecuted under applicable federal or State laws, may lead to a denial, suspension or revocation of the medical laboratory license for this entity, or could result in termination of participation in State or federal reimbursement programs. I further understand that compliance with State laws may not assure compliance with federal laws.

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For Informational Purposes Only

Examples of Testing for Schedule A- General Permit (Do Not Circle)

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To prevent a delay in processing your application please check to make sure all of the following are included:

Completed application with each section completely filled out

Signature of Medical Director must match Director name in section II of application

If the status of your CLIA certificate is changing, a completed CMS 116 form must be submitted

Director Qualifications

Copy of CV, Diploma (highest degree), ECFMG (if applicable), board certification for MD or PhD (if applicable)

Technical Supervisor Qualifications (for the discipline of HISTOLOGY)

Copy of American Pathology Board certification in Anatomical Pathology

Copy of Maryland (Board of Physicians) license to practice medicine

Genetics Testing

Copy of Technical Supervisor’s diploma (must be MD, DO or PhD), board certification from the American Board of Medical Genetics or 4 years of verified (not self-generated) experience in clinical genetics and CV

Copy of Test Menu

Copy of a Validation Study of one test (includes a summary and raw data)

Letter from Director documenting that the lab does not perform “Direct to Consumer” testing

Certificate of Accreditation Laboratories

Copy of enrollment verification from the designated accrediting organization

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