Maryland Department of Health
Office of Health Care Quality
Laboratory Licensing Programs
7120 Samuel Morse Drive
Second Floor
Columbia, Maryland 21046
Phone: 410.402.8025 Fax: 410.402.8213
***Changes to your current State laboratory license must be submitted on the
Laboratory Licensing Change Form. Forms can be downloaded on our website:
https://health.maryland.gov/ohcq/Labs/docs/LabsApps/Laboratory_Licensing_Change_Form.pdf
It is important that you fill out this application completely, including signatures where required. Original (ink)
signatures are required on all initial applications and must be mailed or hand delivered to our office (address listed above).
If the application is incomplete, it will delay the licensing process. Initial applications are not accepted by fax or
email.
Please allow 3-4 weeks for permit processing and mailing
There is no fee for this licensure.
If you have any questions, please call the Laboratory Licensing Division at (410) 402-8025.
***Important***
***Before submitting your application, please review the
checklist on the last page.***
1
Instructions for Completion of State Compliance Application
2
Maryland Department of Health
Laboratory Licensing Programs
Office of Health Care Quality
Date/Amount Paid
Office use only
Invoice # Office use only
Check # Office use only
State Permit #
Applicant, if known please enter
CLIA #
Applicant, if known please enter
State Compliance Application
Initial Application Reinstatement
I. Laboratory Information
Type of Laboratory Physician Office Point of Care Independent/Reference Hospital
Laboratory Practice/ Entity Name Contact Person Name/Phone Number
Address, City, State and Zip Code
Email Address
Fax
Mailing address if different from above
II. Director Information
Laboratory Director Name
Degree
Full Time
Part Time (hours/week)
Certification by American Specialty Board (Name, Date, Number)
State Medical License Number
III. Laboratory Supervisor/Consulting Supervisor/Manager Information
Name
Degree
Full Time
Part Time (hours/week)
Certification by American Specialty Board (Name, Date, Number)
3
IV. Schedule A – General Permit
*** If you are only performing tests on Excepted list, Schedule B, do not use this section***
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
Histocompatibility
V. Schedule B – Excepted Tests *
* Note: Not all tests excepted by Maryland regulations are waived by CLIA. You can check the test categories for CLIA at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/search.cfm
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 vaginalisantigen
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
4
VI. Mandatory, You Must List Testing Instrumentation and Test Kits Used in the Laboratory
***Please also include test discipline/subdiscipline (e.g. Chemistry-Routine) if using Schedule A***
VII. Proficiency Testing
I am not enrolled I am enrolled (complete below)
Name of Company D
iscipline
A.
Type of Entity
VIII. Ownership Information
Sole Proprietorship
Partnership
Corporation
Unincorporated Association
Other (Specify)
B.
This section is MANDATORY, application will be returned if left blank. Social Security Number is unacceptable
Attention- Laboratories not located in Maryland, the EIN must match what you have on file in the CMS CLIA
database. Only include one EIN Number below, not several please.
Name
Address
EIN Federal Tax ID
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.
Signature of Laboratory Director Date
5
For Informational Purposes Only
Examples of Testing for Schedule A- General Permit (Do Not Circle)
Chemistry
Hematology
Alkaline Phosphatase
Amylase
B-HCG (quantitative)
Blood Lead
CK-MB
Digoxin
Iron
Lipase
Phenytoin
T4-Free
Troponin
TSH
Vitamin D
Genetics
Chromosome Analysis
FISH Studies (Neoplastic and Congenital)
Fragile X Screen
Gaucher Disease (GBA) 8 Mutations
Tay-Sachs (HEXA) 7 Mutations
Y Chromosome Deletions
Forensic Toxicology
Job Related Alcohol
Job Related Drugs of Abuse
Microbiology
AFB Smear
Bacterial Culture
Blood Culture
CSF Bacterial Antigen
Fungus/Yeast Culture
Ova and Parasite
Sensitivity Testing
Viral Culture
APTT
CBC
Differential
Fetal Hemoglobin
Fibrinogen
INR
Prothrombin Time
Reticulocyte Count
Sedimentation Rate
Molecular Biology
Adenovirus PCR
BD Affirm Probe Test
Chlamydia PCR
EBV PCR
HCV Genotyping
HIV Drug Resistance Genotyping
HIV Viral Load
Pathology
Dermatopathology
Fine Needle Aspirations
Grossing
Histopathology
Oral Pathology
Other Cytology
Pap Smear Interpretations
Immunology
Anti-Nuclear Antibody
Epstein Barr Antibodies
GM1 Antibody
Hepatitis B Surface Antibody
Hepatitis B Surface Antigen
Herpes Antibody
HIV Antibody
Lyme Antibody
Non Transplant Related Histocompatibility
6
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 Laboratory Director must match the 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
Applicants Located in Maryland Applicants Located Out of State
Completed CLIA application in agreement with State
application
Copy of CLIA certificate and State Laboratory License, if
applicable
Copy of Director’s Maryland (Board of Physicians)
license to practice medicine
Copy of most recent survey, which includes cited deficiencies and
corrective actions
For High Complexity Laboratories: Documentation of training,
education and previous experience that meets CLIA Sec.
493.1443: Standard: Laboratory Director Qualifications
Copy of Director’s State license to practice medicine from the
State where the laboratory is located
For Moderate Complexity Laboratories:
Board Certification or Documentation of 20 CME from
approved programs for Medical Director that meets CLIA
Sec. 493.1405
Documentation of training, education and previous experience
that meets CLIA Sec. 493.1443: Standard: Laboratory Director
Qualifications
Documentation of licensure as a practitioner seeking a Letter
of Exception (midwife, nurse practitioner, etc.
Proof of most recent participation in annual GYN cytology
proficiency testing
