The Maryland State Compliance Application form is a crucial document for laboratories seeking to obtain or renew their state licenses. This form ensures that laboratories comply with the regulations set forth by the Maryland Department of Health and Mental Hygiene's Office of Health Care Quality. Completing this application accurately is essential for a smooth licensing process, which can take 6-8 weeks from submission.
To begin your application, please fill out the form by clicking the button below.
The Maryland State Compliance Application form is a critical document for laboratories seeking to operate within the state’s regulatory framework. It serves as the initial step in obtaining or reinstating a laboratory license, ensuring that facilities meet the necessary health and safety standards set by the Maryland Department of Health and Mental Hygiene. Applicants must provide detailed information about their laboratory, including its type—whether it is a physician's office, independent reference lab, or hospital laboratory. Key sections of the form require the submission of information about the laboratory director and supervisory staff, including their qualifications and certifications. Additionally, the application outlines the types of tests the laboratory intends to perform, categorized under general permits or excepted tests, which helps regulators assess compliance with state regulations. It is essential for applicants to complete the form thoroughly, as any omissions can delay the licensing process. The form also emphasizes the importance of submitting supportive documentation and includes a checklist to guide applicants in ensuring all requirements are met. Once the application is reviewed, an invoice for the application fee will be issued, followed by the issuance of the appropriate license upon payment. For any questions or clarifications, the Laboratory Licensing Division is available to assist, underscoring the state's commitment to facilitating compliance while maintaining high standards of laboratory practice.
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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
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.***
2
Date/Amount Paid
Office use only
State of Maryland
Invoice #
Department of Health and Mental Hygiene
Laboratory Licensing Programs
Check #
Office of Health Care Quality
State Permit #
Applicant, if known please enter
CLIA #
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
III. Laboratory Supervisor/Consulting Supervisor/Manager Information
Name
3
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
Toxicology: Job Related
Bacteriology
Cholesterol/HDL
Blood Gas
Molecular
Parasitology
Other Excepted Tests *
Endocrinology
Cytogenetics
Mycology
Toxicology: Drugs of Abuse
Mycobacteriology
* Excepted tests under
Health Awareness require
Toxicology: Therapeutic
Virology
a General Permit.
Toxicology: Heavy Metals
Radioimmunoassay
Immunohematology
Hematology
Molecular Biology
Pathology
Immunology
ABO/Rh/Non Trans-
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
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
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
4
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
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)
Alkaline Phosphatase
Amylase
B-HCG (quantitative)
Blood Lead
CK-MB
Digoxin
Iron
Lipase
Phenytoin
T4-Free
Troponin
TSH
Vitamin D
Chromosome Analysis
FISH Studies (Neoplastic and Congenital)
Fragile X Screen
Gaucher Disease (GBA) 8 Mutations
Tay-Sachs (HEXA) 7 Mutations
Y Chromosome Deletions
Job Related Alcohol
Job Related Drugs of Abuse
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
Adenovirus PCR
BD Affirm Probe Test
Chlamydia PCR
EBV PCR
HCV Genotyping
HIV Drug Resistance Genotyping
HIV Viral Load
Fine Needle Aspirations
Grossing
Other Cytology
Pap Smear Interpretations
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 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
Many applicants believe they must submit payment along with their application. In reality, the application process begins without any payment. After reviewing the application for completeness, the Department will issue an invoice for the application fee.
Some individuals think that submitting an incomplete application will still lead to a timely review. However, if the application lacks required information or signatures, it will delay the licensing process significantly. It is crucial to ensure all sections are filled out correctly.
There is a belief that one application form fits all laboratory types. This is not the case. Depending on the tests performed, applicants may need to use specific sections of the application or even different forms, particularly if only conducting tests on the Excepted list.
Many applicants expect a quick turnaround after submission. However, the Maryland Department of Health advises that processing can take 6-8 weeks. Patience is necessary as the review process ensures compliance with all regulations.
Completing the Maryland State Compliance Application form is a critical step for laboratories seeking to obtain or renew their licenses. However, many applicants make common mistakes that can lead to delays or complications. Awareness of these pitfalls can streamline the process and ensure that your application is processed smoothly.
One frequent error occurs when applicants fail to provide complete information. Each section of the application must be filled out thoroughly. Omitting details, even seemingly minor ones, can result in the application being deemed incomplete. This not only delays the licensing process but can also lead to unnecessary back-and-forth communication with the licensing division.
Another mistake is neglecting to include the required signatures. The application explicitly states that signatures are necessary in certain areas. Failing to sign can halt the review process, as the application cannot be processed without the proper authorizations. Always double-check for signatures before submission.
In some cases, applicants overlook the importance of the checklist provided on the last page of the application. This checklist serves as a guide to ensure that all necessary documents and information are included. Ignoring this checklist can lead to missing critical components, ultimately causing delays in the processing of the application.
Additionally, applicants sometimes submit payment too early. The instructions clearly state that no money should be sent with the application. Submitting payment prematurely can complicate the application process and may result in confusion regarding fees and invoicing later on.
Another common error is misunderstanding the laboratory type. Applicants must accurately select their laboratory type—whether it’s a physician office, independent reference, or hospital laboratory. Misclassification can lead to inappropriate processing of the application and could impact compliance with state regulations.
Providing incorrect or outdated contact information is also a prevalent mistake. The application requires accurate contact details for the laboratory and its personnel. If these details are incorrect, it can hinder communication and result in missed notifications regarding the application status.
Moreover, applicants may fail to list all testing instrumentation and test kits used in the laboratory. This section is mandatory, and incomplete information can lead to the application being returned. Ensuring that all relevant equipment is documented is essential for compliance and operational clarity.
Lastly, some applicants do not fully understand the attestation section. This part of the application requires a declaration that the information provided is true and complete. Misrepresentations can lead to serious consequences, including denial or revocation of the laboratory license. It is crucial to review all information carefully before signing.
In summary, avoiding these common mistakes when filling out the Maryland State Compliance Application form can save time and reduce frustration. By ensuring completeness, accuracy, and adherence to guidelines, applicants can facilitate a smoother licensing process and focus on what truly matters—providing quality healthcare services.
Complete the Application Thoroughly: It's crucial to fill out every section of the Maryland State Compliance Application form. An incomplete application can lead to delays in the licensing process, so take your time to ensure all information is accurate and complete.
Do Not Submit Payment Initially: At the time of application submission, do not include any payment. After the application is reviewed for completeness, you will receive an invoice detailing the application fee and any other fees required.
Processing Time: Be prepared to wait. The permit processing and invoicing typically take about 6 to 8 weeks. Patience is essential as your application moves through the necessary channels.
Review Required Documentation: Before submitting your application, carefully check page six to ensure you have all the necessary supportive documentation. Missing documents can lead to further delays.
Contact Information: If you have questions during the application process, do not hesitate to reach out. The Laboratory Licensing Division can be contacted at 410-402-8025 for assistance.
When applying for laboratory licensing in Maryland, you may need to submit additional forms and documents alongside the Maryland State Compliance Application. Each of these documents serves a specific purpose in ensuring that your application is complete and meets all necessary regulations. Here are some key forms you might encounter:
Submitting these forms along with your Maryland State Compliance Application can streamline the licensing process. Make sure to review each document carefully to avoid delays in your application.
The Maryland State Compliance Application form is similar to the State Business License Application. Both documents serve as essential tools for entities wishing to operate legally within Maryland. The State Business License Application requires detailed information about the business structure, ownership, and the nature of the services offered. Just like the compliance application, it emphasizes the importance of accuracy and completeness to avoid delays in processing. Both forms require specific signatures and may lead to additional fees once the initial review is complete.
Another document that parallels the Maryland State Compliance Application is the Federal CLIA Application. The Clinical Laboratory Improvement Amendments (CLIA) application is essential for laboratories that wish to perform tests on human specimens. Both applications require detailed information about laboratory operations, including the types of tests performed and the qualifications of the laboratory staff. They also both emphasize the need for compliance with regulatory standards, ensuring that laboratories maintain high-quality testing practices.
The Laboratory Licensing Change Form shares similarities with the Maryland State Compliance Application. This form is used when a laboratory needs to report changes to its existing license, such as changes in ownership or location. Both forms require thorough documentation and signatures to ensure that all changes are accurately recorded. Additionally, both forms play a critical role in maintaining compliance with state regulations, helping to uphold the integrity of laboratory operations.
The Medical Laboratory License Renewal Application is another document that mirrors the Maryland State Compliance Application. Laboratories must submit this application periodically to maintain their operating licenses. Similar to the compliance application, it requires updated information about the laboratory’s operations, personnel, and testing capabilities. Both documents highlight the importance of ongoing compliance with state regulations and require a review process that can lead to additional fees.
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The Laboratory Director's Credential Verification Form is akin to the Maryland State Compliance Application in that it focuses on the qualifications of key personnel. This form is used to verify the credentials of the laboratory director, ensuring they meet the necessary qualifications to oversee laboratory operations. Like the compliance application, it requires precise information and documentation to support the verification process, emphasizing the importance of qualified leadership in maintaining laboratory standards.
The Laboratory Supervisor Credential Verification Form also parallels the Maryland State Compliance Application. This document is crucial for confirming the qualifications of laboratory supervisors, ensuring they are properly certified and trained. Both forms require detailed information about the individual’s credentials and experience, as well as signatures to validate the information provided. Ensuring that supervisory staff are qualified is essential for maintaining the quality of laboratory services.
The Laboratory Quality Assurance Plan is another document that shares characteristics with the Maryland State Compliance Application. This plan outlines the procedures and protocols a laboratory must follow to ensure quality and accuracy in testing. Both documents require a commitment to regulatory compliance and emphasize the importance of maintaining high standards in laboratory operations. They serve as foundational elements in the overall framework of laboratory management and quality control.
Finally, the Laboratory Proficiency Testing Enrollment Form is similar to the Maryland State Compliance Application in its focus on maintaining quality standards. This form is used by laboratories to enroll in proficiency testing programs, which assess their testing accuracy. Both documents require detailed information about the laboratory’s operations and emphasize the importance of ongoing quality assurance. They reflect the commitment to continuous improvement and adherence to regulatory standards in laboratory testing.