Form CMS-116, CLIA Application Instructions

Check this box if your laboratory is accredited by The Joint Commission.

Check this box if your laboratory is accredited by ACHC.

Check this box if your laboratory is accredited by AABB.

Check this box if the laboratory is accredited by the American Association for Laboratory Accreditation (A2LA).

Check this box if the laboratory is accredited by the College of American Pathologists (CAP).

Check this box if the laboratory is accredited by the Commission on Office Laboratory Accreditation (COLA).

Check this box if the laboratory is accredited by the American Society for Histocompatibility and Immunogenetics (ASHI).

Check this box if the laboratory is accredited by another organization not listed and specify the name of the organization.

Enter the name of the accrediting organization for transplant tests.

Enter the name of the accrediting organization for nontransplant procedures.

Enter the name of the accrediting organization for bacteriology tests.

Enter the name of the accrediting organization for mycobacteriology tests.

Enter the name of the accrediting organization for mycology tests.

Enter the name of the accrediting organization for parasitology tests.

Enter the name of the accrediting organization for virology tests.

Enter the name of the accrediting organization for syphilis serology tests.

Enter the name of the accrediting organization for general immunology tests.

Enter the name of the accrediting organization for routine chemistry tests.

Enter the name of the accrediting organization for Urinalysis tests.

Enter the name of the accrediting organization for Endocrinology tests.

Enter the name of the accrediting organization for Toxicology tests.

Enter the name of the accrediting organization for Hematology tests.

Enter the name of the accrediting organization for ABO Group & Rh Group tests.

Enter the name of the accrediting organization for Antibody Detection (transfusion) tests.

Enter the name of the accrediting organization for Antibody Detection (nontransfusion) tests.

Enter the name of the accrediting organization for Antibody Identification tests.

Enter the name of the accrediting organization for compatibility testing.

Enter the name of the accrediting organization for histopathology.

Enter the name of the accrediting organization for oral pathology.

Enter the name of the accrediting organization for cytology.

Enter the name of the accrediting organization for radiobioassay.

Enter the name of the accrediting organization for clinical cytogenetics.

Check this box if additional space is needed and attach additional information using the same format.

Check this box if you need additional space to provide information and attach the additional information using the same format.

Check this box if you are attaching additional information using the same format.

Enter the annual test volume for Hematology tests.

Enter the annual test volume for Immunohematology tests.

Enter the anticipated start date for your laboratory operations.

Enter the effective date for the changes or application.

Check this box if this is your initial application for certification under CLIA.

Check this box if you are applying for a survey.

Check this box if you are requesting a change in the type of certificate.

Check this box if there is a change in the laboratory director.

Check this box if there are other changes. Specify the changes in the text field provided.

Specify any other changes that are not covered by the other options.

Check this box if applying for a Certificate of Waiver and complete Sections I – VI and IX – X.

Check this box if applying for a Certificate for Provider Performed Microscopy Procedures (PPM) and complete Sections I-VII and IX-X.

Check this box if applying for a Certificate of Compliance and complete Sections I – X.

Check this box if applying for a Certificate of Accreditation and complete Sections I – X. Indicate which organization(s) your laboratory is accredited by.

Enter the two-letter abbreviation for the state where the laboratory is located.

Enter the ZIP code for the laboratory's location.

Check this box if the address provided is the physical address of the laboratory.

Check this box if the address provided is the mailing address of the laboratory.

Check this box if the address provided is the corporate address of the laboratory.

Check this box if the address provided is the physical address of the laboratory.

Check this box if the address provided is the mailing address of the laboratory.

Check this box if the address provided is the corporate address of the laboratory.

Enter the street number and name for the laboratory's location.

Enter the city where the laboratory is located.

Enter the two-letter abbreviation for the state where the laboratory is located.

Enter the ZIP code for the laboratory's location.

Enter the name of the laboratory or hospital department.

Enter the address or location of the laboratory, including number, street, and location if applicable.

Enter the city, state, and ZIP code of the laboratory's location.

Enter the telephone number of the laboratory, including the area code.

Enter the name of the laboratory or hospital department applying for the CLIA certification.

Provide the address or location details of the laboratory, including number, street, and any specific location information if applicable.

Enter the city, state, and ZIP code where the laboratory is located.

Provide the telephone number of the laboratory, including the area code.

Select this checkbox if the laboratory is located in a county jurisdiction.

Select this checkbox if the laboratory is located in a state jurisdiction.

Select this checkbox if the laboratory is under federal jurisdiction.

Select this checkbox if the laboratory is under another type of government jurisdiction.

If 'Other Government' is selected, specify the country of the jurisdiction.

Enter the first set of your CLIA Identification Number.

Enter the second set of your CLIA Identification Number.

Enter the name of the facility.

Enter the email address for the facility.

Check this box if you wish to receive notifications, including electronic certificates, via email.

Enter the facility address, including number and street. P.O. Boxes are not allowed.

Enter the city where the facility is located.

Enter the state where the facility is located, using a 2-letter abbreviation.

Enter the ZIP code for the facility.

Enter the federal tax identification number for the facility.

Enter the telephone number for the facility, including the area code.

Enter the fax number for the facility, including the area code.

Enter the mailing or billing address if it is different from the facility address. This address will be used to send the fee coupon or certificate.

Enter the number and street for the mailing or billing address.

Enter the city for the mailing or billing address.

Check this box if the laboratory is a Tissue Bank Repository.

Check this box if the laboratory is part of a Skilled Nursing Facility or Nursing Facility.

Check this box if the laboratory is part of a School or Student Health Service.

Check this box if the laboratory is part of a Rural Health Clinic.

Check this box if the laboratory is a Public Health Laboratory.

Check this box if the laboratory is located in a Prison.

Check this box if the laboratory is operated by a practitioner other than those listed and specify the type of practitioner.

Specify the type of practitioner if the laboratory is operated by a practitioner other than those listed.

Check this box if the laboratory is part of a Pharmacy.

Check this box if the laboratory is part of a Physician Office.

Check this box if the laboratory is a Mobile Laboratory.

Check this box if the laboratory is part of an Intermediate Care Facility for Individuals with Intellectual Disabilities.

Check this box if the laboratory is part of an Insurance company.

Check this box if the laboratory is part of an Industrial facility.

Check this box if the laboratory is an Independent laboratory.

Check this box if the laboratory is part of a Hospital.

Check this box if the laboratory is part of a Hospice.

Check this box if the laboratory is part of a Home Health Agency.

Check this box if the laboratory is part of a Health Maintenance Organization.

Check this box if your laboratory is a Health Fair.

Check this box if your laboratory is a Federally Qualified Health Center.

Check this box if your laboratory is an End Stage Renal Disease Dialysis Facility.

Check this box if your laboratory is a Comprehensive Outpatient Rehabilitation Facility.

Check this box if your laboratory is a Community Clinic.

Check this box if your laboratory is a Blood Bank.

Check this box if your laboratory is an Assisted Living Facility.

Check this box if your laboratory is an Ancillary Testing Site in a Health Care Facility.

Check this box if your laboratory is an Ambulatory Surgery Center.

Check this box if your laboratory is an Ambulance.

Specify the type of laboratory if it does not fall under the listed categories.

Check this box if the laboratory is owned by a city.

Enter the full name of the laboratory director, including last name, first name, and middle initial.

Enter the phone number of the laboratory director.

Enter the credentials of the laboratory director.

Print the name of the director of the laboratory.

Enter the start time for laboratory testing on Sunday in HH:MM format.

Enter the end time for laboratory testing on Sunday in HH:MM format.

Enter the start time for laboratory testing on Monday in HH:MM format.

Enter the end time for laboratory testing on Monday in HH:MM format.

Enter the start time for laboratory testing on Tuesday in HH:MM format.

Enter the end time for laboratory testing on Tuesday in HH:MM format.

Enter the start time for laboratory testing on Wednesday in HH:MM format.

Enter the end time for laboratory testing on Wednesday in HH:MM format.

Enter the start time for laboratory testing on Thursday in HH:MM format.

Enter the end time for laboratory testing on Thursday in HH:MM format.

Enter the start time for laboratory testing on Friday in HH:MM format.

Enter the CLIA number for the first laboratory.

Enter the name of the first laboratory.

Enter the CLIA number for the second laboratory.

Enter the name of the second laboratory.

Enter the CLIA number for the third laboratory.

Enter the name of the third laboratory.

Enter the CLIA number for the fourth laboratory.

Enter the name of the fourth laboratory.

Enter the CLIA number for the fifth laboratory.

Enter the name of the fifth laboratory.

Enter the CLIA number for the sixth laboratory.

Enter the name of the sixth laboratory.

Check this box if your laboratory performs testing 24/7.

Indicate if you are applying for a single site CLIA certificate to cover multiple testing locations. Select 'No' if this does not apply.

Indicate if you are applying for a single site CLIA certificate to cover multiple testing locations. Select 'Yes' if this applies and complete the remainder of this section.

Select 'Yes' if the answer to the corresponding question is affirmative.

Select 'No' if the answer to the corresponding question is negative.

Select 'Yes' if the answer to the corresponding question is affirmative.

Select 'No' if the answer to the corresponding question is negative.

If you answered 'Yes' to the previous question, provide the number of sites under this certificate number and list the name, address, and tests performed for each site.

Select 'Yes' if the answer to the corresponding question is affirmative.

Select 'No' if the answer to the corresponding question is negative.

If you answered 'Yes' to the previous question, provide the number of sites under this certificate number and list the name or department, location within the hospital, and specialty/subspecialty areas performed at each site.

Check this box if additional space is needed and attach the additional information using the same format.

Specify the closing time for the laboratory on Friday.

Specify the opening time for the laboratory on Saturday.

Specify the closing time for the laboratory on Saturday.

Enter the full name of the owner or director of the laboratory. This should be the individual who is responsible for the overall operation and administration of the laboratory.

Provide the signature of the owner or director of the laboratory. This can be done either by signing in ink or using a secure electronic signature.

Enter the date when the form is being signed. Use the format MM/DD/YYYY.

Check this box if the laboratory has a religious affiliation.

Check this box if the laboratory is a private nonprofit organization.

Check this box if the laboratory is another type of nonprofit organization.

Specify the type of nonprofit organization if 'Other Nonprofit' is selected.

Check this box if the laboratory is a proprietary organization.

Select 'Yes' if the laboratory is a foreign entity.

Select 'No' if the laboratory is not a foreign entity.

If 'Yes' is selected, specify the country of origin for the foreign entity.

Check this box if the laboratory performs direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements.

Check this box if the laboratory performs potassium hydroxide (KOH) preparations.

Check this box if the laboratory performs pinworm examinations.

Check this box if the laboratory performs fern tests.

Check this box if the laboratory performs post-coital direct, qualitative examinations of vaginal or cervical mucous.

Check this box if the laboratory performs urine sediment examinations.

Enter the name of the analyte or test for row 4.

Enter the specific name of the test for row 4.

Enter the name of the manufacturer for the test in row 4.

Enter the name of the analyte or test for row 5.

Enter the specific name of the test for row 5.

Enter the name of the manufacturer for the test in row 5.

Enter the name of the analyte or test for row 6.

Enter the specific name of the test for row 6.

Enter the name of the manufacturer for the test in row 6.

Enter the name of the analyte or test for row 7.

Enter the specific name of the test for row 7.

Enter the name of the manufacturer for the test in row 7.

Enter the name of the analyte or test for row 8.

Enter the specific name of the test for row 8.

Enter the name of the manufacturer for the test in row 8.

Enter the name of the analyte or test for row 9.

Enter the specific name of the test for row 9.

Enter the name of the manufacturer for the test in row 9.

Enter the name of the analyte or test for row 10.

Enter the specific name of the test for row 10.

Enter the name of the manufacturer for the test in row 10.

Enter the name of the analyte or test for row 11.

Enter the analyte or test name for the first row.

Enter the test name for the first row.

Enter the manufacturer for the test in the first row.

Enter 'M' for moderate complexity or 'H' for high complexity for the test in the first row.

Enter the analyte or test name for the second row.

Enter the test name for the second row.

Enter the manufacturer for the test in the second row.

Enter 'M' for moderate complexity or 'H' for high complexity for the test in the second row.

Enter the analyte or test name for the third row.

Enter the test name for the third row.

Enter the manufacturer for the test in the third row.

Enter 'M' for moderate complexity or 'H' for high complexity for the test in the third row.

Enter the analyte or test name for the fourth row.

Enter the test name for the fourth row.

Enter the manufacturer for the test in the fourth row.

Specify whether the test is for Microbiology (M) or Hematology (H) for the fourth row.

Enter the name of the analyte or test for the fifth row.

Enter the name of the test for the fifth row.

Enter the name of the manufacturer for the test in the fifth row.

Specify whether the test is for Microbiology (M) or Hematology (H) for the fifth row.

Enter the name of the analyte or test for the sixth row.

Enter the name of the test for the sixth row.

Enter the name of the manufacturer for the test in the sixth row.

Specify whether the test is for Microbiology (M) or Hematology (H) for the sixth row.

Enter the name of the analyte or test for the seventh row.

Enter the name of the test for the seventh row.

Enter the name of the manufacturer for the test in the seventh row.

Specify whether the test is for Microbiology (M) or Hematology (H) for the seventh row.

Enter the name of the analyte or test for the eighth row.

Enter the name of the test for the eighth row.

Enter the name of the manufacturer for the test in the eighth row.

Specify whether the test is for Microbiology (M) or Hematology (H) for the eighth row.

Enter the name of the test being performed in row 11.

Enter the name of the manufacturer for the test in row 11.

Enter the analyte or test being performed in row 12.

Enter the name of the test being performed in row 12.

Enter the name of the manufacturer for the test in row 12.

Enter the analyte or test being performed in row 13.

Enter the name of the test being performed in row 13.

Enter the name of the manufacturer for the test in row 13.

Enter the analyte or test being performed in row 14.

Enter the name of the test being performed in row 14.

Enter the name of the manufacturer for the test in row 14.

Check this box if the test is for transplant purposes.

Check this box if the test is for non-transplant purposes.

Check this box if the laboratory performs bacteriology tests.

Check this box if the laboratory performs mycobacteriology tests.

Check this box if the laboratory performs mycology tests.

Check this box if the laboratory performs parasitology tests.

Check this box if the laboratory performs virology tests.

Check this box if the laboratory performs syphilis serology tests.

Check this box if the laboratory performs general immunology tests.

Check this box if the laboratory performs routine chemistry tests.

Check this box if the laboratory performs histopathology tests.

Check this box if the laboratory performs oral pathology tests.

Check this box if the laboratory performs cytology tests.

Check this box if the laboratory performs radiobioassay tests.

Check this box if the laboratory performs clinical cytogenetics tests.

Indicate the estimated total annual test volume for all waived tests performed.

Check this box if no waived tests are performed.

Enter the estimated total annual test volume for all Provider Performed Microscopy (PPM) tests performed by your laboratory.

Check this box if your laboratory does not perform any Provider Performed Microscopy (PPM) tests.

Enter the annual test volume for histocompatibility.

Provide the annual test volume for microbiology tests performed by the laboratory.

Provide the annual test volume for diagnostic immunology tests performed by the laboratory.

Provide the annual test volume for chemistry tests performed by the laboratory.

Enter the annual test volume for pathology.

Enter the annual test volume for radiobioassay.

Enter the annual test volume for clinical cytogenetics.

Enter the total estimated annual test volume for the laboratory.

List the tests performed, including the specialty and subspecialty for the first category.

List the tests performed, including the specialty and subspecialty for the second category.

List the tests performed, including the specialty and subspecialty for the third category.

List the tests performed, including the specialty and subspecialty for the fourth category.

List the tests performed, including the specialty and subspecialty for the fifth category.

Check this box if your laboratory performs nasal smears for granulocytes.

Check this box if your laboratory performs fecal leukocyte examinations.

Check this box if your laboratory performs qualitative semen analysis, limited to the presence or absence of sperm and detection of motility.

Check this box if your laboratory performs Urinalysis tests.

Check this box if your laboratory performs Endocrinology tests.

Check this box if your laboratory performs Toxicology tests.

Check this box if your laboratory performs Hematology tests.

Check this box if your laboratory performs ABO Group & Rh Group tests.

Check this box if your laboratory performs Antibody Detection (transfusion) tests.

Check this box if your laboratory performs Antibody Detection (nontransfusion) tests.

Check this box if your laboratory performs Antibody Identification tests.

Check this box if your laboratory performs Compatibility Testing.

Identify the waived testing performed by the laboratory. Include each analyte, test system, or device used in the laboratory for the first row.

Enter the name of the test for the first row in the waived testing section.

Provide the name of the manufacturer for the test listed in the first row of the waived testing section.

Identify the waived testing performed by the laboratory. Include each analyte, test system, or device used in the laboratory for the second row.

Enter the name of the test for the second row in the waived testing section.

Provide the name of the manufacturer for the test listed in the second row of the waived testing section.

Identify the waived testing performed by the laboratory. Include each analyte, test system, or device used in the laboratory for the third row.

Enter the name of the test for the third row in the waived testing section.

Provide the name of the manufacturer for the test listed in the third row of the waived testing section.