III. TYPE OF LABORATORY
(Check the one most descriptive of facility type)
01 Ambulance
13 Hospice
22 Practitioner Other (Specify)
02 Ambulatory Surgery Center
14 Hospital
03 Ancillary Testing Site in
15 Independent
23 Prison
Health Care Facility
16 Industrial
24 Public Health Laboratories
04 Assisted Living Facility
17 Insurance
25 Rural Health Clinic
05 Blood Bank
18 Intermediate Care Facilities for
26 School/Student Health Service
06 Community Clinic
Individuals with Intellectual
27 Skilled Nursing Facility/
Disabilities
07 Comp. Outpatient Rehab Facility
Nursing Facility
19 Mobile Laboratory
08 End Stage Renal Disease
28 Tissue Bank/Repositories
Dialysis Facility
20 Pharmacy
29 Other (Specify)
09 Federally Qualified
21 Physician Office
Health Center
Is this a shared lab?
10 Health Fair
Yes
No
11 Health Main. Organization
12 Home Health Agency
IV. HOURS OF LABORATORY TESTING
If testing 24/7 Check Here
(List times during which laboratory testing is performed in HH:MM format)
SUNDAY
MONDAY
TUESDAY
WEDNESDAY
THURSDAY
FRIDAY
SATURDAY
FROM:
TO:
(For multiple sites, attach the additional information using the same format.)
V. MULTIPLE SITES
(must meet one of the regulatory exceptions to apply for this provision in 1-3 below)
Are you applying for a single site CLIA certificate to cover multiple testing locations?
No. If no, go to section VI.
Yes. If yes, complete remainder of this section.
Indicate which of the following regulatory exceptions applies to your facility’s operation.
1.
Is this a laboratory that is not at a fixed location, that is, a laboratory that moves from testing site to testing site, such as
mobile unit providing laboratory testing, health screening fairs, or other temporary testing locations, and may be covered
under the certificate of the designated primary site or home base, using its address?
Yes
No
If yes and a mobile unit is providing the laboratory testing, record the vehicle identification number(s) (VINs) and attach to
the application.
2.
Is this a not-for-profit or Federal, State or local government laboratory engaged in limited (not more than a combination
of 15 moderate complexity or waived tests per certificate) public health testing and filing for a single certificate for
multiple sites?
Yes
No
If yes, provide the number of sites under the certificate
and list name, address and test performed for each
site below.
3.
Is this a hospital with several laboratories located at contiguous buildings on the same campus within the same physical
location or street address and under common direction that is filing for a single certificate for these locations?
Yes
No
If yes, provide the number of sites under this certificate
and list name or department, location within
hospital and specialty/subspecialty areas performed at each site below.
If additional space is needed, check here
and attach the additional information using the same format.
NAME AND ADDRESS/LOCATION
TESTS PERFORMED/SPECIALTY/SUBSPECIALTY
NAME OF LABORATORY OR HOSPITAL DEPARTMENT
ADDRESS/LOCATION (Number, Street, Location if applicable)
TELEPHONE NO. (Include area code)
CITY, STATE, ZIP CODE
NAME OF LABORATORY OR HOSPITAL DEPARTMENT
ADDRESS/LOCATION (Number, Street, Location if applicable)
CITY, STATE, ZIP CODE
TELEPHONE NO. (Include area code)
Form CMS-116 (05/15)
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