Massachusetts General Hospital
CLIA Pre-Application Form
Contact Cliff Leuschen regarding this form at cleuschen@partners.org, fax (617-726-1996), and phone (617-724-0633)
I. Facility information:
Individual Completing New CLIA Certificate Request Form
Extension:
Signature:
Date:
Facility Name:
Main Extension:
Full Laboratory Name:
Days and Hours of Operation
Facility Address (Physical location of Laboratory, including building, floor, and suite, if applicable)
Number and Street
City, State, Zip Code
Service or Department
Extension:
Chief of Service or Department
Extension:
Do you need a CLIA Certificate?

Does your testing provide clinical results used to assess patients health status?
YES

Does your testing provide results for research?

Does your testing fall into one of the four exception categories listed below (circle)?
YES
NO
NO
YES
NO
CLIA applies to virtually all laboratories testing of human specimens. For example, a physician’s office, health fair, school,
nursing home, and any facility performing any laboratory test used for health purposes, no matter how simple or routine, are
subject to the CLIA requirements. Specifically, the law applies to any: “biological, microbiological, serological, cytological,
chemical, immunohematolgical, hematological, biophysical, cytological, pathological, or other examination of materials derived
from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or
impairment of, or the assessment of, human beings.”
There are very limited exceptions. CLIA does NOT apply to:
1. Any laboratory that conducts testing solely for forensic purposes
2. Research laboratories that test human specimens, but do not report any patient-specific results for the diagnosis,
treatment, or assessment of the health of individual patients;
3. Persons, such as home health agency employees, who only assist patients in their home with testing kits approved by
the Food and Drug Administration for personal use; or
4. Individuals or entities which serve as collection stations, but which send all specimens out to a certified laboratory for
analysis.
II. To be completed by Business Manager:
Business Manager (Print Name):
Extension:
Business Manager Signature:
Tax ID:
Circle appropriate responses
Are expenses for this testing being paid by a GH budget or PO Budget?
GH
PO
Other
Do you now or do you plan to bill through the GH or MGPO billing system?
GH
PO
Other
III. Testing to be performed (expand as needed, refer to test list on page 3):
Estimated # of tests to
Test Name:
Method, Kit and/or Instrument: be performed yearly:
IV. To be completed by MGH Pathology
Reviewed by: ____________________________
Reviewed by: ____________________________
Date: __________________________________
Date: __________________________________
Comments:
Comments:
Reviewed by: ___________________________
Reviewed by: ____________________________
Date: __________________________________
Date: __________________________________
Comments:
Comments:
Determined to be:
Type of Certificate:
Non-waived:
Waived:
PPMP:
Organization:
Affiliated Lab:
Point of Care:
Other:
Location:
Offsite:
Onsite:
Test List
Gram Stain
Glucose (glucometry)
Hematocrit or Hemoglobin
Cooximetry (Hb, HbO2, O2, Sat)
(Pulse oximetry is not a POC test)
Coagulation Tests
• Prothrombin Time (INR)
• Partial thromboplastin time (APTT)
• Activated clotting time (ACT)
Hemoccult (Occult Blood)
Streptococcus (Rapid Strep)
Urine Dipstick (visual, manual)
Urine Dipstick (automated)
Pregnancy, Urine (uHCG)
Pregnancy, Serum (HCG)
Urine Microscopy
Fungus Slide Prep (KOH)
Cervicovaginal or skin wet mount microscopy (Wet Prep)
Fern Test
Post-coital qualitative cervicovaginal microscopy
Pinworm Examination
Tzanck Prep
Chemistries (Na, K, CO2, Glu, iCA, Lactate)
Blood gasses (PO2, PCO2, pH)
Nitrazine pH
Amniotest pH
Rapid flu detection