Fill a Valid Maryland State Compliance Application Template

Fill a Valid Maryland State Compliance Application Template

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.

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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

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

 

 

 

 

 

Invoice #

Office use only

 

Department of Health and Mental Hygiene

 

 

 

 

 

 

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

 

 

 

 

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

Genetics

Forensic Toxicology

Microbiology

Health Awareness

Routine

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-

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

 

 

 

 

 

 

 

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

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

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

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

Misconceptions

  • Misconception 1: The Maryland State Compliance Application requires payment upfront.
  • 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.

  • Misconception 2: Incomplete applications will be processed anyway.
  • 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.

  • Misconception 3: Any laboratory can use the same application form, regardless of the type of testing.
  • 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.

  • Misconception 4: Once submitted, the application will be processed immediately.
  • 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.

Common mistakes

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.

Key takeaways

  • 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.

Documents used along the form

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:

  • Laboratory Licensing Change Form: Use this form to report any changes to your existing laboratory license. This could include changes in ownership, location, or laboratory personnel. It’s essential to keep your license information current.
  • Commercial Lease Agreement Form: It’s important to have a clear understanding of the https://floridadocuments.net/fillable-commercial-lease-agreement-form to ensure both landlord and tenant rights are protected in any commercial property leasing situation.
  • Proficiency Testing Enrollment Form: If your laboratory conducts proficiency testing, this form is necessary to show that you are enrolled in a recognized proficiency testing program. This helps ensure the quality and reliability of your lab results.
  • Ownership Disclosure Form: This document requires you to disclose the ownership structure of your laboratory. Providing accurate information here is crucial, as it helps the state understand who is responsible for the laboratory’s operations.
  • Application Fee Invoice: After your application is reviewed, you will receive an invoice detailing the fees associated with your application. This document is essential for processing your payment and obtaining your laboratory license.

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.

Similar forms

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.