Maryland Department of Health
Office of Health Care Quality – Laboratory Licensing
7120 Samuel Morse Drive
Office Use Only
Date Received:
Second
Floor
Columbia,
Maryland
21046
Date Completed:
Phone:
410.402.8025
Fax: 410.402.8213
Please provide us with the changes in the fields below along with the effective date of the
change.
For a change of Director, a copy of the Director’s medical license, medical diploma and board certification
must be submitted. Please send diploma, board certification and CV for a PhD Director.
CLIA certificate of compliance and PPM labs must submit a CLIA 116 application as well to update
director.
CLIA certificate of accreditation labs must contact their accreditation agency to update director.
***THIS FORM MUST BE SIGNED BY THE DIRECTOR FOR ALL CHANGES TO BE VALID***
Please return this form by fax:
410-402-8213
Current Name of Lab:
State Lab ID # Federal CLIA #: Is this CLIA a multisite? Y N
Mailing/Billing Address:
Telephone #:
Fax #:
Email: __________________________________
Date of Change:
Date of Change:
Date of Change:
Date of Change:
Date of Change:
Date of Change:
Date of Change:
Date of Change: _
Date of Change: ______________
Laboratory Name:
Owner:
Tax ID #:
Director:
Physical Address:
Laboratory Licensing Change Form
2
Please list specific tests you are adding or deleting, indicate for each test the instrument/kit and
manufacturer used as well as the effective date of change. Please also use the test menu page,
Schedule A and B to list the testing discipline that will appear on the license
Changes/Additions/Deletions to Tests
Test Name Kit/Instrument Used Add Delete Date of Change
Change State License Status to:
Letter of Exception General Permit Date of Change:
Change my CLIA Certification Status to: (must submit with a CMS-116, both forms must then be mailed to our address)
Waiver Compliance Provider Performed Microscopic Procedures (PPMP)
Accreditation with which program?
Date of Change:
Our office has closed and/or discontinued all clinical testing. Date of Change:
Print Laboratory Director’s Name:
Laboratory Director’s Signature: Date:
Check to request an updated CLIA certificate. CMS fees may be applied for this request.
3
Chemistry
Routine
Blood Gas
Endocrinology
Toxicology: Drugs of Abuse
Toxicology: Therapeutic
Toxicology: Heavy Metals
Radioimmunoassay
Genetics
Routine
Molecular
Cytogenetics
Forensic Toxicology
Toxicology: Job Related
Microbiology
Bacteriology
Parasitology
Mycology
Mycobacteriology
Virology
Health Awareness *
Cholesterol/Lipids
Glucose Finger Stick
Hemoglobin A1c
* performed at health fairs
not routine chemistry lab
*must be CLIA waived
Immunohematology/
Blood Bank
ABO/Rh/Non Trans-
fusion/Transplant
ABO/Rh
Antibody Detection
Antibody Identification
Compatibility Testing
Hematology
Routine
Coagulation
□ CLIA Waived
CBC (Sysmex)
Molecular Biology
Nucleic Acid Probes
PCR Amplifications
Recombinant Nucleic Acid
Techniques
Pathology
Histopathology
Dermatopathology
Oral Pathology
Cytology–GYN
Cytology–Non- GYN
Immunology
General Immunology
Syphilis Serology
Histocompatability
Chemistry
CLIA waived blood lipid analysis for cholesterol, HDL, LDL,
and triglycerides.
Hematology
Fern Test
Hematocrit
Hemoglobin
Nitrazine Test
Semen analysis, qualitative
Sickle Cell Testing
CLIA Waived PT/INR
Dipstick Glucose BNP
Dipstick Urinalysis Microscopic Urinalysis
Dipstick Microalbumin & creatinine, urine
Fructosamine (whole blood)
Glucose (FDA Home Device)
Hemoglobin A1c (Glycohemoglobin)
Waived Whole Blood Lead Testing
CLIA Waived Urine Drug Screen
Immunology
Microbiology
Bladder marker, H-related protein, qualitative
H.Pylori (whole blood)
Dermatophyte Screen Trichomonas vaginalis antigen
Bacterial Sialidase
Heterophyle AG (whole blood)
Mono Slide Test
NMP Bladder Marker, qualitative
Rheumatoid Factor
Gram Stain Adenovirus antigen eye fluid
Group A Strep Screen (non-culture)
Influenza Antigen (nasal or throat swab)
KOH Preparation
Urine Pregnancy Test
Occult Blood
Occult Blood, gastric
Pinworm Prep
Urine Colony Count (no ID)
Wet Mount