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Fill Out Your Maryland State Compliance Application Template

The Maryland State Compliance Application form is a crucial document for laboratories seeking to obtain or renew their state license. This application ensures that laboratories meet the necessary health and safety standards as set by the Maryland Department of Health and Mental Hygiene. Completing this form accurately and thoroughly is essential to avoid delays in the licensing process.

If you're ready to begin your application, please fill out the form by clicking the button below.

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Fill Out Your Maryland State Compliance Application Template

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Dos and Don'ts

When filling out the Maryland State Compliance Application form, it is essential to follow specific guidelines to ensure a smooth process. Here are nine important dos and don'ts to keep in mind:

Do fill out the application completely, ensuring all sections are addressed.
Don't submit any payment with the application; an invoice will be issued after review.
Do include all required signatures where indicated.
Don't leave any mandatory fields blank; incomplete applications will be returned.
Do review the checklist on the last page before submission.
Don't forget to verify that you have included the correct supportive documentation.
Do allow 6-8 weeks for processing and invoicing after submission.
Don't submit changes to your current license on this form; use the Laboratory Licensing Change Form instead.
Do contact the Laboratory Licensing Division at (410) 402-8025 if you have questions.

Misconceptions

Misconceptions about the Maryland State Compliance Application Form

All applications require payment upfront. Many believe they must submit payment with their application. However, payment is only required after the application has been reviewed for completeness.
Incomplete applications will be processed anyway. Some think that submitting an incomplete application will still lead to processing. In reality, any missing information will delay the licensing process.
Only large laboratories need to apply. There’s a misconception that only large or commercial labs need a license. In fact, all types of laboratories, including physician offices and independent labs, must comply with licensing requirements.
Changing laboratory information is a simple process. Many assume that minor changes can be made easily. Changes must be submitted on the Laboratory Licensing Change Form, which is a separate process.
All tests performed are automatically compliant. Some applicants believe that if they perform tests listed in the application, they are compliant. However, not all tests exempted by Maryland regulations are waived by CLIA.
Documentation is optional. A common misconception is that supportive documentation isn’t necessary. In fact, applicants must verify they have the correct documentation before submission.
The application process is quick. Some expect immediate results after submission. In reality, applicants should allow 6-8 weeks for processing and invoicing.
Contacting the licensing division is unnecessary. Many think they can navigate the application process alone. However, reaching out to the Laboratory Licensing Division for questions can clarify doubts and ensure compliance.

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Key takeaways

Complete the Application: Ensure that all sections of the Maryland State Compliance Application are filled out completely, including required signatures. An incomplete application will delay processing.
Do Not Submit Payment Initially: Do not send any payment with your application. After review, you will receive an invoice for the application fee.
Review the Checklist: Before submission, carefully check the checklist on the last page of the application to confirm you have included all necessary documents.
Processing Time: Expect a processing time of 6 to 8 weeks for your application. Be patient as the review takes time.
Contact Information: If you have questions, reach out to the Laboratory Licensing Division at 410-402-8025 for assistance.
Correct Documentation: Verify that you have the appropriate supportive documentation as outlined on page six of the application.
Changes to Existing License: If you need to make changes to your current state laboratory license, use the Laboratory Licensing Change Form available on the Maryland Department of Health's website.

Guidelines on Utilizing Maryland State Compliance Application

Completing the Maryland State Compliance Application form requires careful attention to detail. This process involves providing accurate information about the laboratory, its director, and the tests performed. Following these steps will help ensure that the application is filled out correctly and submitted without delay.

Obtain the Maryland State Compliance Application form from the Maryland Department of Health and Mental Hygiene website or the appropriate office.
Fill in the laboratory information section, including the type of laboratory, practice or entity name, contact person’s name and phone number, address, email, and fax number. If the mailing address differs, provide that as well.
Complete the director information section by entering the director's name, degree, employment status (full-time or part-time), certification details, and state medical license number.
Provide information for the laboratory supervisor or consulting supervisor/manager, including their name, degree, employment status, certification details, and any relevant information.
In Schedule A, indicate the types of tests your laboratory will perform. If only excepted tests will be conducted, skip this section and proceed to Schedule B.
For Schedule B, list the excepted tests that your laboratory will perform. Ensure that you check the Maryland regulations to confirm the tests that qualify.
List all testing instrumentation and test kits used in the laboratory. Include the test discipline or sub-discipline for clarity.
Indicate your proficiency testing status. If enrolled, provide the name of the company and the discipline.
Fill out the ownership information section, specifying the type of entity and providing the necessary identification information, such as the EIN or Federal Tax ID.
Complete the attestation section by signing and dating the form, certifying that all information provided is true and complete.

After submitting the application, it will undergo a review process. If the application is complete and compliant with regulations, an invoice for the application fee will be issued. The processing time typically takes 6-8 weeks. It is advisable to keep a copy of the completed application for your records.

Form Preview Example

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

Instructions for Completion of State Compliance Application

***Changes to your current State laboratory license must be submitted on the Laboratory Licensing Change Form. The form can be downloaded on our website at www.dhmh.state.md.us/ohcq ***

It is important that you fill out this application completely, including signatures where required. If the application is incomplete it will delay the licensing process.

Please submit no money at this time. Once your application is reviewed for completeness and compliance with the applicable regulations, you will be issued an invoice for the application fee as well as other fees as outlined in COMAR 10.10.04.02.

Please allow 6-8 weeks for permit processing and invoicing.

Once your payment is received, the appropriate license will be issued.

Please review page six of this application, to verify you have the correct supportive documentation.

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.***

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

	Date/Amount Paid	Office use only
State of Maryland
State of Maryland	Invoice #	Office use only
Department of Health and Mental Hygiene	Invoice #	Office use only
Department of Health and Mental Hygiene
Laboratory Licensing Programs
Laboratory Licensing Programs	Check #	Office use only
Office of Health Care Quality
	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

Director Name	Degree	Full Time	Part Time (hours/week)

Certification by American Specialty Board (Name, Date, Number)		State Medical License 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)

IV. Schedule A – General Permit

*** If you are only performing tests on Excepted list, Schedule B, do not use this section***

Chemistry	Genetics	Forensic Toxicology	Microbiology	Health Awareness
Routine	Routine	Toxicology: Job Related	Bacteriology	Cholesterol/HDL
Blood Gas	Molecular		Parasitology	Other Excepted Tests *
Blood Gas
Endocrinology	Cytogenetics		Mycology
Endocrinology
Toxicology: Drugs of Abuse			Mycobacteriology	* Excepted tests under
Toxicology: Drugs of Abuse				Health Awareness require
Toxicology: Therapeutic			Virology	Health Awareness require
Toxicology: Therapeutic				a General Permit.
Toxicology: Heavy Metals				a General Permit.
Toxicology: Heavy Metals
Radioimmunoassay

Immunohematology	Hematology	Molecular Biology	Pathology	Immunology
ABO/Rh/Non Trans-	Routine	Nucleic Acid Probes	Histopathology	General Immunology
fusion/Transplant	Coagulation	PCR Amplifications	Dermatopathology	Syphilis Serology
ABO/Rh		Recombinant Nucleic Acid	Oral Pathology	Histocompatability
Antibody Detection		Techniques	Cytology–GYN
Antibody Identification			Cytology–Non- GYN
Compatibility Testing

	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		Hematology
BNP		Fern Test
Dipstick Glucose		Hematocrit
Dipstick Urinalysis		Hemoglobin
Dipstick Microalbumin & creatinine, urine		Nitrazine Test
Fructosamine (whole blood)		Semen analysis, qualitative
Glucose (FDA Home Device)		Sickle Cell Testing
Hemoglobin A1c (Glycohemoglobin)		CLIA Waived PT/INR
Microscopic Urinalysis
Urine or saliva drug or alcohol for approved counselors
CLIA Waived blood lipids for cholesterol, HDL, LDL,	and
Triglycerides

Immunology		Microbiology
Bladder marker, H-related protein, qualitative		Dermatophyte Screen	Trichomonas vaginalis antigen
H.Pylori (whole blood)		Fecal Fat	Bacterial Sialidase
Heterophyle AG (whole blood)		Gram Stain	Adenovirus antigen eye fluid
Mono Slide Test		Group A Strep Screen (non-culture)
NMP Bladder Marker, qualitative		Influenza Antigen (nasal or throat swab)
Rheumatoid Factor		KOH Preparation
Urine Pregnancy Test		Occult Blood
		Occult Blood, gastric
		Pinworm Prep
		Urine Colony Count (no ID)
		Wet Mount

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

I am not enrolled

I am enrolled (complete below)

Name of Company	Discipline
__________________________________________	____________________________________________
__________________________________________	____________________________________________
__________________________________________	____________________________________________
__________________________________________	____________________________________________

VIII. Ownership Information

A. Type of Entity

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

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

For Informational Purposes Only

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

Chemistry

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

Hematology

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

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

____________________________________________________________________________________________

Applicants Located in Maryland

Completed CLIA application in agreement with State application

Copy of Director’s Maryland (Board of Physicians) license to practice medicine

For High Complexity Laboratories: Documentation

of training, education and previous experience

that meets CLIA Sec. 493.1443: Standard:

Laboratory Director Qualifications

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 licensure as a practitioner seeking a Letter of Exception (midwife, nurse practitioner, PA, chiropractor, podiatrist, dentist)

Applicants Located Out of State

Copy of CLIA certificate and State Laboratory License, if applicable

Copy of most recent survey, which includes cited deficiencies and corrective actions

Copy of Director’s State license to practice medicine from the State where the laboratory is located

Documentation of training, education and previous experience that meets CLIA Sec. 493.1443: Standard: Laboratory Director Qualifications

Proof of most recent participation in annual GYN cytology proficiency testing

Common mistakes

Incomplete Information: One of the most common mistakes is failing to fill out all sections of the application. Each part must be completed to avoid delays in processing.
Missing Signatures: Applicants often forget to sign the form where required. Signatures are crucial as they confirm the accuracy of the information provided.
Incorrect Documentation: Submitting the wrong or insufficient supporting documents can lead to rejection of the application. It's essential to review the checklist on the last page before submission.
Ignoring Instructions: Some applicants overlook the specific instructions for completion. Carefully reading the guidelines can prevent common errors.
Not Following Up: After submitting the application, many people fail to follow up. Checking the status can help address any issues that may arise during processing.

Free Maryland State Compliance Application PDF

Learn More on This Form

What is the Maryland State Compliance Application form used for?

The Maryland State Compliance Application form is used to apply for a laboratory license in the state of Maryland. It is essential for laboratories that wish to operate legally and comply with state regulations. The application must be completed in full, including necessary signatures, to avoid delays in the licensing process.

How long does it take to process the application?

After submission, the processing of the application typically takes 6 to 8 weeks. During this time, the application will be reviewed for completeness and compliance with applicable regulations. Once reviewed, an invoice for the application fee will be issued. The appropriate license will be granted upon receipt of payment.

What should I do if I need to make changes to my current laboratory license?

If changes are needed for an existing laboratory license, the Laboratory Licensing Change Form must be submitted. This form can be downloaded from the Maryland Department of Health and Mental Hygiene's website. It is important to use the correct form to ensure that the changes are processed efficiently.

Is there an application fee, and when is it due?

There is an application fee associated with the Maryland State Compliance Application. However, applicants should not submit any payment at the time of application. Once the application is reviewed and deemed complete, an invoice for the fee will be sent to the applicant. Payment must be made upon receipt of the invoice for the license to be issued.

What documentation is required to accompany the application?

Applicants must review page six of the application to verify that they have included all necessary supportive documentation. This may include certifications, licenses, and other relevant information about the laboratory and its personnel. Incomplete applications will delay processing.

How can I contact the Laboratory Licensing Division if I have questions?

If you have any questions regarding the Maryland State Compliance Application or the licensing process, you can contact the Laboratory Licensing Division at (410) 402-8025. It is advisable to reach out for clarification on any aspects of the application to ensure compliance and completeness.