Form CMS-116, CLIA Application Instructions
This form contains 297 fields organized into 94 sections. Below is a complete list of every field, its type, and what information is expected.
| Field Name | Type | Description |
|---|---|---|
| ABO Group & Rh Group Information | ||
| ABO Group & Rh Group 510 | Checkbox |
Check this box if your laboratory performs testing for ABO Group & Rh Group 510. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| ABO Group & Rh Group Accrediting Organization | Text |
Please provide the name of the Accreditation Organization for the ABO Group & Rh Group specialty, if applicable for CLIA compliance. Fill only if 'ABO Group & Rh Group 510' is 'Yes'.
Depends on:
ABO Group & Rh Group 510
|
| Accreditation Organizations | ||
| The Joint Commission | Checkbox |
Check this box if your laboratory is accredited by The Joint Commission for CLIA purposes, or if you have applied for accreditation from The Joint Commission for CLIA purposes. Fill only if 'Certificate of Accreditation' is 'Yes'.
Depends on:
Certificate of Accreditation
|
| ACHC | Checkbox |
Check this box if your laboratory is accredited by ACHC for CLIA purposes, or if you have applied for accreditation from ACHC for CLIA purposes. Fill only if 'Certificate of Accreditation' is 'Yes'.
Depends on:
Certificate of Accreditation
|
| AABB | Checkbox |
Check this box if your laboratory is accredited by AABB for CLIA purposes, or if you have applied for accreditation from AABB for CLIA purposes. Fill only if 'Certificate of Accreditation' is 'Yes'.
Depends on:
Certificate of Accreditation
|
| A2LA | Checkbox |
Check this box if your laboratory is accredited by A2LA for CLIA purposes, or if you have applied for accreditation from A2LA for CLIA purposes. Fill only if 'Certificate of Accreditation' is 'Yes'.
Depends on:
Certificate of Accreditation
|
| CAP | Checkbox |
Check this box if your laboratory is accredited by CAP for CLIA purposes, or if you have applied for accreditation from CAP for CLIA purposes. Fill only if 'Certificate of Accreditation' is 'Yes'.
Depends on:
Certificate of Accreditation
|
| COLA | Checkbox |
Check this box if your laboratory is accredited by COLA for CLIA purposes, or if you have applied for accreditation from COLA for CLIA purposes. Fill only if 'Certificate of Accreditation' is 'Yes'.
Depends on:
Certificate of Accreditation
|
| ASHI | Checkbox |
Check this box if your laboratory is accredited by ASHI for CLIA purposes, or if you have applied for accreditation from ASHI for CLIA purposes. Fill only if 'Certificate of Accreditation' is 'Yes'.
Depends on:
Certificate of Accreditation
|
| Additional Space Checkbox | ||
| Additional Space Needed | Checkbox |
Check this box if additional space is needed to provide information and attach the additional information using the specified format. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Additional Space Information | ||
| Additional Space Needed | Checkbox |
Check this box if you need additional space to provide information and will attach it using the same format. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Antibody Detection (nontransfusion) Information | ||
| Antibody Detection (nontransfusion) | Checkbox |
Check this box if your laboratory performs Antibody Detection (nontransfusion) testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Annual Test Volume for Antibody Detection (Nontransfusion) | Number |
Enter the estimated annual test volume for Antibody Detection (Nontransfusion), excluding testing not subject to CLIA, waived tests, or tests run for quality control, calculations, quality assurance or proficiency testing. Fill only if 'Antibody Detection (nontransfusion)' is 'Yes'.
Depends on:
Antibody Detection (nontransfusion)
|
| Antibody Detection (transfusion) Information | ||
| Antibody Detection (transfusion) | Checkbox |
Check this box if the laboratory performs antibody detection testing for transfusion purposes. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Annual Test Volume (Transfusion) | Number |
Enter the estimated annual test volume for antibody detection (transfusion). Fill only if 'Antibody Detection (transfusion)' is 'Yes'.
Depends on:
Antibody Detection (transfusion)
|
| Antibody Identification Information | ||
| Antibody Identification | Checkbox |
Check this box if the laboratory performs non-waived antibody identification testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Antibody Identification Annual Test Volume | Number |
Provide the estimated annual test volume for Antibody Identification 540. Fill only if 'Antibody Identification' is 'Yes'.
Depends on:
Antibody Identification
|
| Application Information | ||
| Initial Application | Checkbox |
Check this box if you are submitting a new application for certification.
|
| Anticipated Start Date | Date |
Please provide the anticipated date when the application activities are expected to begin. Fill only if 'Initial Application' is 'Yes'.
Depends on:
Initial Application
|
| Survey | Checkbox |
Check this box if this application is in response to a survey or inspection.
|
| Change in Certificate Type | Checkbox |
Check this box if you are requesting a change in the type of your CLIA certificate.
|
| Change in Laboratory Director | Checkbox |
Check this box if there is a change in the laboratory director.
|
| Other Changes (Specify) | Checkbox |
Check this box if you are reporting other types of changes not listed above and specify them.
|
| Other Changes Specification | Text |
Please provide a detailed description of any other changes not listed above that are relevant to this application. Fill only if 'Other Changes (Specify)' is 'Yes'.
Depends on:
Other Changes (Specify)
|
| Effective Date of Change | Date |
Please provide the effective date when these changes will take effect. Fill only if 'Change in Certificate Type', 'Change in Laboratory Director', 'Other Changes (Specify)' is 'Yes' for any.
Depends on:
Change in Certificate Type, Change in Laboratory Director, Other Changes (Specify)
|
| Bacteriology Information | ||
| Bacteriology 110 | Checkbox |
Check this box if your laboratory performs Bacteriology testing for specialty code 110. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Bacteriology 110 Accrediting Organization | Text |
Provide the name of the accrediting organization for Bacteriology 110 if applying for a Certificate of Accreditation. Fill only if 'Bacteriology 110' is 'Yes'.
Depends on:
Bacteriology 110
|
| Certificate Address Selection | ||
| Physical | Checkbox |
Check this box if the certificate should be sent to the physical location of the laboratory.
|
| Mailing | Checkbox |
Check this box if the certificate should be sent to the specified mailing address.
|
| Corporate | Checkbox |
Check this box if the certificate should be sent to the corporate address.
|
| Chemistry Annual Test Volume | ||
| Chemistry Annual Test Volume | Number |
Provide the estimated annual test volume for the Chemistry specialty. Fill only if 'Routine 310', 'Urinalysis 320', 'Endocrinology 330', 'Toxicology 340' is 'Yes', any.
Depends on:
Routine 310, Urinalysis 320, Endocrinology 330, Toxicology 340
|
| CLIA Identification Number | ||
| CLIA ID Prefix | Text |
Provide the first part of your CLIA Identification Number before the 'D' separator. Fill only if 'Initial Application' is 'No'.
Depends on:
Initial Application
|
| CLIA ID Suffix | Text |
Provide the second part of your CLIA Identification Number after the 'D' separator. Fill only if 'Initial Application' is 'No'.
Depends on:
Initial Application
|
| Clinical Cytogenetics Annual Test Volume | ||
| Clinical Cytogenetics Annual Test Volume | Number |
Enter the estimated annual test volume for Clinical Cytogenetics. Fill only if 'Clinical Cytogenetics' is 'Yes'.
Depends on:
Clinical Cytogenetics
|
| Clinical Cytogenetics Information | ||
| Clinical Cytogenetics | Checkbox |
Check this box if the laboratory performs Clinical Cytogenetics testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Clinical Cytogenetics Annual Test Volume | Number |
Provide the estimated annual test volume for Clinical Cytogenetics. Fill only if 'Clinical Cytogenetics' is 'Yes'.
Depends on:
Clinical Cytogenetics
|
| Compatibility Testing Information | ||
| Compatibility Testing 550 | Checkbox |
Check this box if the laboratory performs Compatibility Testing 550. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Compatibility Testing Annual Volume | Number |
Enter the estimated annual test volume for Compatibility Testing 550. Fill only if 'Compatibility Testing 550' is 'Yes'.
Depends on:
Compatibility Testing 550
|
| Corporate Address | ||
| Corporate Street Address | Text |
Enter the street number and name for the corporate address. Fill only if 'Street Address', 'City', 'State', 'Zip Code' is different from facility address.
Depends on:
Street Address, City, State, Zip Code
|
| Corporate City | Text |
Enter the city for the corporate address. Fill only if 'Street Address', 'City', 'State', 'Zip Code' is different from facility address.
Depends on:
Street Address, City, State, Zip Code
|
| Corporate State | Text |
Enter the state for the corporate address. Fill only if 'Street Address', 'City', 'State', 'Zip Code' is different from facility address.
Depends on:
Street Address, City, State, Zip Code
|
| Corporate Zip Code | Text |
Enter the zip code for the corporate address. Fill only if 'Street Address', 'City', 'State', 'Zip Code' is different from facility address.
Depends on:
Street Address, City, State, Zip Code
|
| Cytology Information | ||
| Cytology 630 | Checkbox |
Check this box if the laboratory performs testing in the Cytology 630 subspecialty. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Cytology Annual Test Volume | Number |
Please provide the estimated annual test volume for Cytology testing. Fill only if 'Cytology 630' is 'Yes'.
Depends on:
Cytology 630
|
| Diagnostic Immunology Annual Test Volume | ||
| Syphilis Serology Annual Test Volume | Number |
Enter the estimated annual test volume for Syphilis Serology, excluding testing not subject to CLIA, waived tests, or tests run for quality control, calculations, quality assurance, or proficiency testing. Fill only if 'Syphilis Serology', 'General Immunology' is 'Yes', any.
Depends on:
Syphilis Serology, General Immunology
|
| Director Information | ||
| Director's Name | Text |
Please provide the full name of the laboratory director, including last, first, and middle initial.
|
| Director's Phone Number | Text |
Please enter the laboratory director's phone number.
|
| Director's Credentials | Text |
Please list the credentials of the laboratory director.
|
| Eighth Non-Waived Test | ||
| Eighth Non-Waived Analyte/Test | Text |
Enter the analyte, test system, or device used for the eighth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Eighth Non-Waived Test Name | Text |
Enter the name of the eighth non-waived test performed. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Eighth Non-Waived Manufacturer | Text |
Enter the manufacturer of the test system or device used for the eighth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Eighth Non-Waived Complexity (M or H) | Text |
Indicate the complexity of the eighth non-waived test by entering 'M' for moderate or 'H' for high. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Eighth Waived Test | ||
| Eighth Analyte / Test | Text |
Please provide the name of the analyte or test for the eighth waived test listed. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Eighth Test Name | Text |
Please provide the specific name of the eighth waived test system or device. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Eighth Manufacturer | Text |
Please provide the manufacturer of the eighth waived test system or device. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Eleventh Waived Test | ||
| Eleventh Waived Test Analyte / Test | Text |
Provide the analyte or test for the eleventh waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Eleventh Waived Test Name | Text |
Provide the name of the eleventh waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Eleventh Waived Test Manufacturer | Text |
Provide the manufacturer of the eleventh waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Endocrinology Information | ||
| Endocrinology 330 | Checkbox |
Check this box if the laboratory performs testing in the Endocrinology 330 subspecialty. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Endocrinology Annual Test Volume | Number |
Enter the estimated annual test volume for Endocrinology 330. Fill only if 'Endocrinology 330' is 'Yes'.
Depends on:
Endocrinology 330
|
| Facility Contact Information | ||
| Email Address | Text |
Please provide the email address for the facility.
|
| Receive Notifications via Email | Checkbox |
Check this box if you wish to receive notifications, including electronic certificates, via email.
|
| Telephone Number | Text |
Please enter the facility's telephone number, including the area code.
|
| Fax Number | Text |
Please enter the facility's fax number, including the area code.
|
| Facility Name | ||
| Facility Name | Text |
Please provide the legal name of the facility.
|
| Facility Physical Address | ||
| Street Address | Text |
Enter the street number and name for the physical location of the facility, excluding P.O. Boxes.
|
| City | Text |
Enter the city for the physical location of the facility.
|
| State | Text |
Enter the state for the physical location of the facility.
|
| Zip Code | Text |
Enter the zip code for the physical location of the facility.
|
| Federal Tax Identification Number | ||
| Federal Tax Identification Number | Text |
Please provide the Federal Tax Identification Number for the facility.
|
| Fee Coupon Address Selection | ||
| Physical | Checkbox |
Check this box if the fee coupon should be sent to the physical location of the laboratory.
|
| Mailing | Checkbox |
Check this box if the fee coupon should be sent to the specified mailing/billing address.
|
| Corporate | Checkbox |
Check this box if the fee coupon should be sent to the corporate address.
|
| Fifth Additional Laboratory | ||
| Fifth Additional Laboratory CLIA Number | Text |
Provide the CLIA number for the fifth additional laboratory where the director is affiliated.
|
| Fifth Additional Laboratory Name | Text |
Provide the name of the fifth additional laboratory where the director is affiliated.
|
| Fifth Non-Waived Test | ||
| Fifth Analyte / Test | Text |
Please enter the name of the analyte, test system, or device used for the fifth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Fifth Test Name | Text |
Please enter the specific name of the test for the fifth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Fifth Manufacturer | Text |
Please enter the name of the manufacturer of the test for the fifth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Fifth Complexity Level | Text |
Please indicate the complexity level for the fifth non-waived test, using 'M' for moderate or 'H' for high. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Fifth Waived Test | ||
| ANALYTE / TEST ROW 5 | Text |
Enter the name of the analyte or test for row 5. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| TEST NAME 5 | Text |
Enter the specific name of the test for row 5. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| MANUFACTURER ROW 5 | Text |
Enter the name of the manufacturer for the test in row 5. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| First Additional Laboratory | ||
| CLIA Number | Text |
Please provide the CLIA number for the first additional laboratory.
|
| Name of Laboratory | Text |
Please provide the name of the first additional laboratory.
|
| First Laboratory Information | ||
| Laboratory Name | Text |
Enter the full name of the laboratory or hospital department. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Laboratory Address | Text |
Enter the street number, street name, and any additional location information for the laboratory. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| City, State, Zip Code | Text |
Enter the city, state, and zip code of the laboratory. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Telephone Number | Text |
Enter the telephone number of the laboratory, including the area code. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Tests Performed / Specialty 1 | Text |
List the types of tests performed, specialties, or subspecialties of the laboratory. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Tests Performed / Specialty 2 | Text |
List additional types of tests performed, specialties, or subspecialties of the laboratory. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Tests Performed / Specialty 3 | Text |
List further types of tests performed, specialties, or subspecialties of the laboratory. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| First Non-Waived Test | ||
| Analyte / Test | Text |
Please enter the specific analyte or test that will be performed. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Test Name | Text |
Please provide the full name of the test being performed. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Manufacturer | Text |
Please enter the name of the manufacturer of the test system or device. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Complexity (M or H) | Text |
Please indicate the complexity of the test by entering 'M' for moderate complexity or 'H' for high complexity. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| First Waived Test | ||
| First Waived Test Analyte/Test | Text |
Please provide the name of the analyte or test performed for the first waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| First Waived Test Name | Text |
Please provide the name of the test system or device used for the first waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| First Waived Test Manufacturer | Text |
Please provide the name of the manufacturer for the first waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Foreign Entity Ownership Information | ||
| Yes | Radiobutton |
Check this box if the facility has partial or full ownership or control by a non-United States-based government or entity.
|
| No | Radiobutton |
Check this box if the facility does not have partial or full ownership or control by a non-United States-based government or entity.
|
| Country of Origin for Foreign Entity | Text |
Please provide the country of origin for the foreign entity. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| Fourteenth Waived Test | ||
| Fourteenth Waived Test Analyte/Test | Text |
Provide the analyte or test name for the fourteenth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Fourteenth Waived Test Name | Text |
Provide the specific test name for the fourteenth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Fourteenth Waived Test Manufacturer | Text |
Provide the name of the manufacturer for the fourteenth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Fourth Additional Laboratory | ||
| Fourth Additional Laboratory CLIA Number | Text |
Enter the CLIA number for the fourth additional laboratory.
|
| Fourth Additional Laboratory Name | Text |
Enter the name of the fourth additional laboratory.
|
| Fourth Non-Waived Test | ||
| Analyte / Test | Text |
Provide the name of the analyte or the specific test performed. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Test Name | Text |
Enter the full name of the non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Manufacturer | Text |
Provide the name of the manufacturer of the test system or device used. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Complexity Level | Text |
Indicate the complexity level of the test, using 'M' for moderate or 'H' for high. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Fourth Waived Test | ||
| Analyte / Test 4 | Text |
Please provide the name of the analyte or test for this waived testing. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Test Name 4 | Text |
Please provide the specific name of the test system or device used for this waived testing. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Manufacturer 4 | Text |
Please provide the name of the manufacturer for this waived testing system or device. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| General Immunology Information | ||
| General Immunology | Checkbox |
Check this box if your laboratory performs general immunology testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| General Immunology Annual Test Volume | Number |
Please provide the estimated annual test volume for General Immunology. Fill only if 'General Immunology' is 'Yes'.
Depends on:
General Immunology
|
| Hematology Annual Test Volume | ||
| Hematology 400 Annual Test Volume | Number |
Provide the estimated annual test volume for the Hematology 400 specialty. Fill only if 'Hematology' is 'Yes'.
Depends on:
Hematology
|
| Hematology Information | ||
| Hematology | Checkbox |
Check this box if the laboratory performs Hematology testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Hematology Annual Test Volume | Number |
Please provide the estimated annual test volume for the Hematology specialty, excluding tests not subject to CLIA, waived tests, or tests run for quality control, calculations, quality assurance, or proficiency testing. Fill only if 'Hematology' is 'Yes'.
Depends on:
Hematology
|
| Histocompatibility Annual Test Volume | ||
| Histocompatibility 010 Annual Test Volume | Number |
Please enter the estimated annual test volume for Histocompatibility 010 testing. Fill only if 'Transplant', 'Nontransplant' is 'Yes', any.
Depends on:
Transplant, Nontransplant
|
| Histopathology Information | ||
| Histopathology | Checkbox |
Check this box if the laboratory performs Histopathology testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Histopathology Annual Test Volume | Number |
Provide the estimated annual test volume for Histopathology 610. Fill only if 'Histopathology' is 'Yes'.
Depends on:
Histopathology
|
| Hours of Laboratory Testing | ||
| 24/7 Testing | Checkbox |
Check this box if laboratory testing is performed 24 hours a day, 7 days a week, and you do not need to list specific hours.
|
| Sunday From Time | Time |
Enter the time from which laboratory testing is performed on Sunday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Sunday To Time | Time |
Enter the time until which laboratory testing is performed on Sunday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Monday From Time | Time |
Enter the time from which laboratory testing is performed on Monday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Monday To Time | Time |
Enter the time until which laboratory testing is performed on Monday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Tuesday From Time | Time |
Enter the time from which laboratory testing is performed on Tuesday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Tuesday To Time | Time |
Enter the time until which laboratory testing is performed on Tuesday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Wednesday From Time | Time |
Enter the time from which laboratory testing is performed on Wednesday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Wednesday To Time | Time |
Enter the time until which laboratory testing is performed on Wednesday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Thursday From Time | Time |
Enter the time from which laboratory testing is performed on Thursday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Thursday To Time | Time |
Enter the time until which laboratory testing is performed on Thursday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Friday From Time | Time |
Enter the time from which laboratory testing is performed on Friday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Friday To Time | Time |
Enter the time until which laboratory testing is performed on Friday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Saturday From Time | Time |
Enter the time from which laboratory testing is performed on Saturday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Saturday To Time | Time |
Enter the time until which laboratory testing is performed on Saturday. Fill only if '24/7 Testing' is 'No'.
Depends on:
24/7 Testing
|
| Immunohematology Annual Test Volume | ||
| Immunohematology Annual Test Volume | Number |
Enter the estimated annual test volume for Immunohematology. Fill only if 'ABO Group & Rh Group 510', 'Antibody Detection (transfusion)', 'Antibody Detection (nontransfusion)', 'Antibody Identification', 'Compatibility Testing 550' is 'Yes', any.
Depends on:
ABO Group & Rh Group 510, Antibody Detection (transfusion), Antibody Detection (nontransfusion), Antibody Identification, Compatibility Testing 550
|
| Mailing/Billing Address | ||
| Mailing/Billing Address Line 1 | Text |
Enter the first line of the mailing or billing address, which may include a building name, floor, or suite number.
|
| Mailing/Billing Street Address | Text |
Enter the street number and name for the mailing or billing address, avoiding P.O. Boxes.
|
| Mailing/Billing City | Text |
Enter the city for the mailing or billing address.
|
| Mailing/Billing State | Text |
Enter the state for the mailing or billing address.
|
| Mailing/Billing Zip Code | Text |
Enter the zip code for the mailing or billing address.
|
| Microbiology Annual Test Volume | ||
| Microbiology Annual Test Volume | Number |
Provide the estimated annual test volume for the Microbiology specialty. Fill only if 'Bacteriology 110', 'Mycobacteriology 115', 'Mycology 120', 'Parasitology 130', 'Virology 140' is 'Yes', any.
Depends on:
Bacteriology 110, Mycobacteriology 115, Mycology 120, Parasitology 130, Virology 140
|
| Multiple Testing Locations Application | ||
| No | Checkbox |
Check this box if you are not applying for a single site CLIA certificate to cover multiple testing locations and should proceed to section VI.
|
| Yes | Checkbox |
Check this box if you are applying for a single site CLIA certificate to cover multiple testing locations and should complete the remainder of this section.
|
| Mycobacteriology Information | ||
| Mycobacteriology 115 | Checkbox |
Check this box if your laboratory performs testing in the Mycobacteriology 115 subspecialty. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Mycobacteriology Annual Test Volume | Number |
Enter the estimated annual test volume for the Mycobacteriology 115 subspecialty. Fill only if 'Mycobacteriology 115' is 'Yes'.
Depends on:
Mycobacteriology 115
|
| Mycology Information | ||
| Mycology 120 | Checkbox |
Check this box if your laboratory performs testing in the Mycology 120 subspecialty. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Mycology 120 Annual Test Volume | Number |
Enter the estimated annual test volume for Mycology 120. Fill only if 'Mycology 120' is 'Yes'.
Depends on:
Mycology 120
|
| Ninth Waived Test | ||
| Analyte or Test | Text |
Please provide the name of the analyte or the type of test performed for this waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Test Name | Text |
Please enter the specific name of the test system or device used for this waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Manufacturer | Text |
Please provide the name of the manufacturer of the test system or device for this waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Nontransplant Information | ||
| Nontransplant | Checkbox |
Check this box if the laboratory performs nontransplant histocompatibility testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Nontransplant Annual Test Volume | Number |
Enter the estimated annual test volume for nontransplant testing in the Histocompatibility 010 specialty. Fill only if 'Nontransplant' is 'Yes'.
Depends on:
Nontransplant
|
| Oral Pathology Information | ||
| Oral Pathology | Checkbox |
Check this box if the laboratory performs Oral Pathology testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Oral Pathology Annual Test Volume | Number |
Provide the estimated annual test volume for Oral Pathology. Fill only if 'Oral Pathology' is 'Yes'.
Depends on:
Oral Pathology
|
| Ownership Information | ||
| SIGNATURE OF OWNER/DIRECTOR OF LABORATORY (SIGN IN INK OR USE A SECURE ELECTRONIC SIGNATURE) | Signature |
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.
|
| Parasitology Information | ||
| Parasitology 130 | Checkbox |
Check this box if your laboratory performs testing in the Parasitology subspecialty (ID 130). Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Parasitology 130 Annual Test Volume | Number |
Enter the estimated annual test volume for Parasitology 130. Fill only if 'Parasitology 130' is 'Yes'.
Depends on:
Parasitology 130
|
| Pathology Annual Test Volume | ||
| Histopathology Annual Test Volume | Number |
Enter the estimated annual test volume for Histopathology 610. Fill only if 'Histopathology', 'Oral Pathology', 'Cytology 630' is 'Yes', any.
Depends on:
Histopathology, Oral Pathology, Cytology 630
|
| PPM Procedures | ||
| Direct wet mount preparations | Checkbox |
Check this box if direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Potassium hydroxide (KOH) preparations | Checkbox |
Check this box if Potassium hydroxide (KOH) preparations are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Pinworm examinations | Checkbox |
Check this box if Pinworm examinations are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Fern tests | Checkbox |
Check this box if Fern tests are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Post-coital direct examinations | Checkbox |
Check this box if post-coital direct, qualitative examinations of vaginal or cervical mucous are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Urine sediment examinations | Checkbox |
Check this box if urine sediment examinations are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Nasal smears for granulocytes | Checkbox |
Check this box if nasal smears for granulocytes are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Fecal leukocyte examinations | Checkbox |
Check this box if fecal leukocyte examinations are performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Qualitative semen analysis | Checkbox |
Check this box if qualitative semen analysis (limited to the presence or absence of sperm and detection of motility) is performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| PPM Testing Summary | ||
| PPM Tests Annual Volume | Number |
Provide the estimated total annual volume for all PPM tests performed. Fill only if 'Check if no PPM tests are performed' is 'No'.
Depends on:
Check if no PPM tests are performed
|
| Check if no PPM tests are performed | Checkbox |
The user should check this box if their facility does not perform any PPM tests. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate for Provider Performed Microscopy Procedures (PPM)'.
Depends on:
Certificate for Provider Performed Microscopy Procedures (PPM)
|
| If additional space is needed, check here | Checkbox |
The user should check this box if they need to attach additional information because the provided space for PPM test details is insufficient. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate for Provider Performed Microscopy Procedures (PPM)'.
Depends on:
Certificate for Provider Performed Microscopy Procedures (PPM)
|
| Print Name of Director of Laboratory | ||
| Director's Printed Name | Text |
Provide the printed full name of the laboratory's director.
|
| Print Name of Owner of Laboratory | ||
| Printed Name of Owner | Text |
Please enter the full printed name of the laboratory's owner.
|
| Radiobioassay Annual Test Volume | ||
| Radiobioassay Annual Test Volume | Number |
Enter the estimated annual test volume for Radiobioassay procedures. Fill only if 'Radiobioassay' is 'Yes'.
Depends on:
Radiobioassay
|
| Radiobioassay Information | ||
| Radiobioassay | Checkbox |
Check this box if your laboratory performs radiobioassay testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Radiobioassay Volume | Number |
Enter the estimated annual test volume for the Radiobioassay specialty. Fill only if 'Radiobioassay' is 'Yes'.
Depends on:
Radiobioassay
|
| Regulatory Exception for Hospital Laboratories | ||
| Yes | Radiobutton |
Check this box if your facility is a hospital with several laboratories located at contiguous buildings on the same campus within the same physical location or street address and is filing for a single certificate for these locations. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| No | Radiobutton |
Check this box if your facility is not a hospital with several laboratories located at contiguous buildings on the same campus within the same physical location or street address, or if you are not filing for a single certificate for these locations. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| Number of Sites Under Certificate (Hospital) | Number |
Enter the total number of sites that are located within contiguous buildings on the same hospital campus and are filing under this single certificate. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| Regulatory Exception for Non-Fixed Laboratory | ||
| Yes | Radiobutton |
Check this box if your laboratory is not at a fixed location and moves between testing sites, such as a mobile unit or for health screening fairs. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| No | Radiobutton |
Check this box if your laboratory operates from a fixed location and does not move between testing sites. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| Regulatory Exception for Non-Profit/Government Laboratory | ||
| Yes | Radiobutton |
Check this box if your facility is a not-for-profit or Federal, State, or local government laboratory engaged in limited public health testing and is filing for a single certificate for multiple sites. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| No | Radiobutton |
Check this box if your facility is not a not-for-profit or Federal, State, or local government laboratory engaged in limited public health testing and is not filing for a single certificate for multiple sites. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| Number of Sites Under Certificate | Number |
Enter the total number of sites covered by the certificate. Fill only if 'Yes' is 'Yes'.
Depends on:
Yes
|
| Routine Chemistry Information | ||
| Routine 310 | Checkbox |
Check this box if the laboratory performs routine chemistry testing (code 310). Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Routine Chemistry Annual Test Volume | Number |
Enter the estimated annual test volume for routine chemistry testing. Fill only if 'Routine 310' is 'Yes'.
Depends on:
Routine 310
|
| Second Additional Laboratory | ||
| Second Lab CLIA Number | Text |
Provide the CLIA number for the second additional laboratory where the director serves.
|
| Second Lab Name | Text |
Provide the name of the second additional laboratory where the director serves.
|
| Second Laboratory Information | ||
| Second Laboratory Name | Text |
Provide the name of the second laboratory or hospital department. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Second Laboratory Address | Text |
Provide the street number, street name, and location of the second laboratory or hospital department. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Second Laboratory City, State, Zip Code | Text |
Provide the city, state, and zip code for the second laboratory or hospital department. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Second Laboratory Telephone Number | Text |
Provide the telephone number for the second laboratory or hospital department, including the area code. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Second Laboratory Tests Performed/Specialty | Text |
List the tests performed, specialty, or subspecialty for the second laboratory or hospital department. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Second Laboratory Tests Performed/Specialty (Additional) | Text |
Provide additional tests performed, specialty, or subspecialty details for the second laboratory or hospital department, if needed. Fill only if 'Yes', 'Yes' is 'Yes' for any.
Depends on:
Yes, Yes
|
| Second Non-Waived Test | ||
| Second Analyte / Test | Text |
Provide the name of the analyte or test performed for the second non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Second Test Name | Text |
Provide the specific name of the second non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Second Manufacturer | Text |
Provide the name of the manufacturer for the second non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Second Complexity (M or H) | Text |
Indicate the complexity of the second non-waived test by entering 'M' for moderate or 'H' for high. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Second Waived Test | ||
| Second Waived Test Analyte | Text |
Please provide the analyte or test performed for the second waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Second Waived Test Name | Text |
Please provide the name of the second waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Second Waived Test Manufacturer | Text |
Please provide the manufacturer of the second waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Seventh Non-Waived Test | ||
| Seventh Analyte/Test | Text |
Provide the name of the analyte, test system, or device for the seventh non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Seventh Test Name | Text |
Enter the specific name of the test performed for the seventh non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Seventh Manufacturer | Text |
Provide the name of the manufacturer for the seventh non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Seventh Complexity Level | Text |
Indicate the complexity level of the seventh non-waived test by entering 'M' for moderate or 'H' for high. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Seventh Waived Test | ||
| Seventh Waived Test Analyte/Test | Text |
Provide the analyte, test system, or device used for the seventh waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Seventh Waived Test Name | Text |
Provide the specific name of the seventh waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Seventh Waived Test Manufacturer | Text |
Provide the manufacturer of the seventh waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Signature Date | ||
| Signature Date | Date |
Enter the date the signature was provided.
|
| Sixth Additional Laboratory | ||
| CLIA Number | Text |
Provide the Clinical Laboratory Improvement Amendments (CLIA) number for the sixth additional laboratory.
|
| Laboratory Name | Text |
Provide the full name of the sixth additional laboratory.
|
| Sixth Non-Waived Test | ||
| Sixth Non-Waived Test Analyte | Text |
Please provide the analyte, test system, or device used for the sixth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Sixth Non-Waived Test Name | Text |
Please provide the name of the sixth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Sixth Non-Waived Test Manufacturer | Text |
Please provide the manufacturer of the sixth non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Sixth Non-Waived Test Complexity | Text |
Please indicate the complexity of the sixth non-waived test, using 'M' for moderate or 'H' for high. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Sixth Waived Test | ||
| Sixth Waived Test Analyte | Text |
Enter the name of the analyte or test performed for the sixth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Sixth Waived Test Name | Text |
Enter the specific name of the test system or device used for the sixth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Sixth Waived Test Manufacturer | Text |
Enter the name of the manufacturer of the test system or device used for the sixth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Syphilis Serology Information | ||
| Syphilis Serology | Checkbox |
Check this box if the laboratory performs Syphilis Serology testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Annual Test Volume for Syphilis Serology | Number |
Please provide the estimated annual test volume for Syphilis Serology 210. Fill only if 'Syphilis Serology' is 'Yes'.
Depends on:
Syphilis Serology
|
| Tenth Waived Test | ||
| Tenth Waived Test Analyte / Test | Text |
Please provide the name of the analyte or test performed for the tenth waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Tenth Waived Test Name | Text |
Please provide the specific test system or device name for the tenth waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Tenth Waived Test Manufacturer | Text |
Please provide the name of the manufacturer for the tenth waived test system or device. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Third Additional Laboratory | ||
| Third Additional Laboratory CLIA Number | Text |
Please provide the CLIA number for the third additional laboratory.
|
| Third Additional Laboratory Name | Text |
Please provide the name of the third additional laboratory.
|
| Third Non-Waived Test | ||
| Third Non-Waived Test Analyte | Text |
Provide the specific analyte or test performed for this third non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Third Non-Waived Test Name | Text |
Enter the full name of the test performed for this third non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Third Non-Waived Test Manufacturer | Text |
Specify the manufacturer of the test system or device used for this third non-waived test. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Third Non-Waived Test Complexity | Text |
Indicate the complexity level of this third non-waived test as either 'M' for moderate or 'H' for high. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Third Waived Test | ||
| Third Waived Test Analyte | Text |
Enter the name of the analyte or test for the third waived testing entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Third Waived Test System Name | Text |
Enter the name of the test system or device used for the third waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Third Waived Test Manufacturer | Text |
Enter the manufacturer of the test system or device for the third waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Thirteenth Waived Test | ||
| Thirteenth Waived Test Analyte | Text |
Please provide the name of the analyte or test performed for the thirteenth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Thirteenth Waived Test Name | Text |
Please provide the name of the test system or device used for the thirteenth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Thirteenth Waived Test Manufacturer | Text |
Please provide the manufacturer of the test system or device used for the thirteenth waived test. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Total Estimated Annual Test Volume | ||
| Total Estimated Annual Test Volume | Number |
Provide the total estimated annual test volume across all specialties and sites. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Toxicology Information | ||
| Toxicology 340 | Checkbox |
Check this box if the laboratory performs testing in the Toxicology 340 subspecialty. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Toxicology 340 Annual Test Volume | Number |
Enter the estimated annual test volume for the Toxicology 340 specialty. Fill only if 'Toxicology 340' is 'Yes'.
Depends on:
Toxicology 340
|
| Transplant Information | ||
| Transplant | Checkbox |
Check this box if the laboratory performs testing for transplant under Histocompatibility. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
|
| Transplant Annual Test Volume | Number |
Please enter the estimated annual test volume for transplant testing related to Histocompatibility 010. Fill only if 'Transplant' is 'Yes'.
Depends on:
Transplant
|
| Twelfth Waived Test | ||
| Twelfth Analyte/Test | Text |
Provide the analyte or test performed for the twelfth waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Twelfth Test Name | Text |
Enter the name of the test system or device used for the twelfth waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Twelfth Manufacturer | Text |
State the manufacturer of the test system or device used for the twelfth waived test entry. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
|
| Type of Certificate Requested | ||
| Certificate of Waiver | Checkbox |
Check this box if you are requesting a Certificate of Waiver for your laboratory.
|
| Certificate for Provider Performed Microscopy Procedures (PPM) | Checkbox |
Check this box if you are requesting a Certificate for Provider Performed Microscopy Procedures (PPM) for your laboratory.
|
| Certificate of Compliance | Checkbox |
Check this box if you are requesting a Certificate of Compliance for your laboratory.
|
| Certificate of Accreditation | Checkbox |
Check this box if you are requesting a Certificate of Accreditation for your laboratory and will indicate the accrediting organization(s).
|
| Type of Control | ||
| Religious Affiliation | Checkbox |
Check this box if the ownership type is a voluntary nonprofit with a religious affiliation.
|
| Private Nonprofit | Checkbox |
Check this box if the ownership type is a private nonprofit organization.
|
| Other Nonprofit | Checkbox |
Check this box if the ownership type is a voluntary nonprofit that does not fall under religious affiliation or private, requiring further specification.
|
| Other Nonprofit Specification | Text |
Provide a detailed description of the other nonprofit organization type. Fill only if 'Other Nonprofit' is selected.
Depends on:
Other Nonprofit
|
| Proprietary | Checkbox |
Check this box if the ownership type is a for-profit proprietary entity.
|
| City | Checkbox |
Check this box if the ownership type is a government entity at the city level.
|
| County | Checkbox |
Check this box if the ownership type is a government entity at the county level.
|
| State | Checkbox |
Check this box if the ownership type is a government entity at the state level.
|
| Federal | Checkbox |
Check this box if the ownership type is a government entity at the federal level.
|
| Other Government | Checkbox |
Check this box if the ownership type is another form of government entity not specifically listed, requiring further specification.
|
| Other Government Jurisdiction | Text |
Specify the country or province if 'Other Government' is selected as the control type. Fill only if 'Other Government' is selected.
Depends on:
Other Government
|
| Type of Laboratory | ||
| Other (Specify) | Checkbox |
Check this box if the laboratory type is not listed and specify the type.
|
| Tissue Bank/Repositories | Checkbox |
Check this box if the laboratory type is a tissue bank or repository.
|
| Skilled Nursing Facility/Nursing Facility | Checkbox |
Check this box if the laboratory type is a skilled nursing facility or nursing facility.
|
| School/Student Health Service | Checkbox |
Check this box if the laboratory type is a school or student health service.
|
| Rural Health Clinic | Checkbox |
Check this box if the laboratory type is a rural health clinic.
|
| Public Health Laboratories | Checkbox |
Check this box if the laboratory type is a public health laboratory.
|
| Prison | Checkbox |
Check this box if the laboratory type is a prison.
|
| Practitioner Other (Specify) | Checkbox |
Check this box if the laboratory type is practitioner-related but not listed, and specify the type.
|
| Practitioner Other Specification | Text |
Please specify the type of practitioner if 'Practitioner Other' is selected. Fill only if 'Practitioner Other (Specify)' is 'Yes'.
Depends on:
Practitioner Other (Specify)
|
| Pharmacy | Checkbox |
Check this box if the laboratory type is a pharmacy.
|
| Physician Office | Checkbox |
Check this box if the laboratory type is a physician's office.
|
| Mobile Laboratory | Checkbox |
Check this box if the laboratory type is a mobile laboratory.
|
| Intermediate Care Facilities for Individuals with Intellectual Disabilities | Checkbox |
Check this box if the laboratory type is an intermediate care facility for individuals with intellectual disabilities.
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| Insurance | Checkbox |
Check this box if the laboratory type is related to insurance.
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| Industrial | Checkbox |
Check this box if the laboratory type is industrial.
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| Independent | Checkbox |
Check this box if the laboratory type is independent.
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| Hospital | Checkbox |
Check this box if the laboratory type is a hospital.
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| Hospice | Checkbox |
Check this box if the laboratory type is a hospice.
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| Home Health Agency | Checkbox |
Check this box if the laboratory type is a home health agency.
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| Health Main. Organization | Checkbox |
Check this box if the laboratory type is a health maintenance organization.
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| Health Fair | Checkbox |
Check this box if the laboratory type is a health fair.
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| Federally Qualified Health Center | Checkbox |
Check this box if the laboratory type is a federally qualified health center.
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| End Stage Renal Disease Dialysis Facility | Checkbox |
Check this box if the laboratory type is an end-stage renal disease dialysis facility.
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| Comp. Outpatient Rehab Facility | Checkbox |
Check this box if the laboratory type is a comprehensive outpatient rehabilitation facility.
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| Community Clinic | Checkbox |
Check this box if the laboratory type is a community clinic.
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| Blood Bank | Checkbox |
Check this box if the laboratory type is a blood bank.
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| Assisted Living Facility | Checkbox |
Check this box if the laboratory type is an assisted living facility.
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| Ancillary Testing Site in Health Care Facility | Checkbox |
Check this box if the laboratory type is an ancillary testing site in a health care facility.
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| Ambulatory Surgery Center | Checkbox |
Check this box if the laboratory type is an ambulatory surgery center.
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| Ambulance | Checkbox |
Check this box if the laboratory type is an ambulance.
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| Other Laboratory Type Specification | Text |
Please specify the type of laboratory if 'Other' is selected. Fill only if 'Other (Specify)' is 'Yes'.
Depends on:
Other (Specify)
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| Urinalysis Information | ||
| Urinalysis 320 | Checkbox |
Check this box if the laboratory performs Urinalysis 320 testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
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| Urinalysis Annual Test Volume | Number |
Please enter the estimated annual test volume for Urinalysis. Fill only if 'Urinalysis 320' is 'Yes'.
Depends on:
Urinalysis 320
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| Virology Information | ||
| Virology 140 | Checkbox |
Check this box if the laboratory performs Virology 140 testing. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Compliance' or 'Certificate of Accreditation'.
Depends on:
Certificate of Compliance, Certificate of Accreditation
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| Virology 140 Annual Test Volume | Number |
Enter the estimated annual test volume for the Virology 140 subspecialty, excluding tests not subject to CLIA, waived tests, or those performed for quality control, calculations, quality assurance, or proficiency testing. Fill only if 'Virology 140' is 'Yes'.
Depends on:
Virology 140
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| Waived Testing Summary | ||
| Estimated Total Annual Test Volume | Number |
Enter the estimated total annual volume for all waived tests performed. Fill only if 'No Waived Tests' is 'No'.
Depends on:
No Waived Tests
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| No Waived Tests | Checkbox |
Check this box if no waived tests are performed by your facility. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Waiver'.
Depends on:
Certificate of Waiver
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| Additional Space Needed | Checkbox |
Check this box if you require additional space to list waived tests and will attach additional information using the same format. Fill only if 'TYPE OF CERTIFICATE REQUESTED' is 'Certificate of Waiver'.
Depends on:
Certificate of Waiver
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