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Application Information:
Because the information about each facility is used for multiple purposes,
it is essential that the information on the application be checked closely for
accuracy. The information on the MTS license application form is entered into
the MTS computer system in Seattle as well as into the Federal
Health and Human Services Centers for Medicare and Medicaid Services (CMS)
computer system in Baltimore. The information that is
entered into the CMS
computer is accessed by Medicare and Medicaid for
reimbursing laboratory claims to providers.
The information needed on the MTS application includes:
FEDERAL TAX ID NUMBER (EIN #):
This should be the number used for tax reporting purposes for the
facility. When a facility originally applies to an insurance company to be
eligible to obtain reimbursement, the Tax ID Number is required information.
It is essential that the number used on insurance applications, tax reports
and the MTS license be identical.
NAME OF FACILITY:
The name listed on the application form should be the name you routinely
use to identify your facility. This is the name that should be used when you
order proficiency testing, if applicable, to cover the regulated analytes
(tests) performed by your facility. Regulated
tests are listed on Pages 6-7 of the license application in bold print
SITE ADDRESS / MAILING ADDRESS:
The site address is the physical location of the facility. The mailing
address should be listed ONLY if it is DIFFERENT than the site
address. If you have a Billing address, i.e., an address where you
would like your fee statement sent that is different from either the site
address or the mailing address, please write that information on the
application and clearly label "Billing Address".
TELEPHONE NUMBER, FAX NUMBER:
T he area code and phone/fax numbers.
OWNER:
List the name of the owner(s) of the facility.
DIRECTOR:
List the name of the person who acts as the medical director for the
facility. It is important to include the qualifications of the named director,
i.e., MD, PhD, BS, etc. Only one person should be listed as the director of
the facility. If multiple names are listed, only the first name will be
considered as the director. A person may serve as the medical director for up
to five separate MTS licensed sites.
CONTACT PERSON:
List the person who is best suited to act as the contact person for the
facility. This should be the person that LQA should contact to verify
information about the facility, proficiency testing problems and for
scheduling on-site inspections. List email address if available.
SITE TYPE:
Check the type of site that best describes your facility.
MULTIPLE SITES:
To be eligible for a multiple-site license, the facility must qualify as a
NOT-FOR-PROFIT or state or local government facility that performs limited
public health testing (a total of 15 or fewer waived or moderate complexity
tests) at different locations.
If your facility qualifies for a multiple-site license, you MUST
submit along with your initial application:
- A copy of your federal 501(c)(3) tax determination letter from the
Internal Revenue Service (IRS) if you are not a state or local government
laboratory;
- A list of names and addresses for each site that will be included under
one license. If any of the sites already have a MTS license, include
the MTS and CLIA numbers of the sites that will be consolidated under this
license;
- A listing of the tests performed at each facility including the number of
regulated analytes (tests)
performed per year (regulated analytes are listed in bold print on Pages 6-7 of the license application form);
Total number of regulated analytes (tests) performed by all sites
listed under the appropriate specialty area on Pages 6-7 of the license
application form.
NOTE: Only one license will be issued for a multiple-site facility.
It
is the responsibility of the medical test site to make copies of the license
for each separate facility.
ACCREDITED LABORATORIES:
If your laboratory is accredited AND INSPECTED by one of the private
accrediting organizations approved by the Federal
Health and Human Services Centers for Medicare and Medicaid Services (CMS), you qualify for the ACCREDITED
LICENSE category.
The approved accrediting organizations include:
NOTE:
JCAHO and the Office of Laboratory Quality Assurance have entered into a reciprocal recognition
agreement. This agreement means that, in Washington, a JCAHO-accredited
facility may choose to have its laboratory areas inspected under the Medical
Test Site (MTS) law or
JCAHO.
To qualify for an MTS Accredited License, you MUST include proof of
accreditation or certification by the accreditation organization that lists
the approved specialties with your application. For JCAHO
accreditation, a copy of the Laboratory Accreditation Certificate or a copy of
the front page of the accreditation report that lists all CLIA numbers that
have been reviewed is required. If you have not yet been inspected by the
accrediting organization, include proof of enrollment with your
application and forward the proof of accreditation after the inspection has
been completed.
NOTE: If you are only participating in proficiency testing programs from
one of the above organizations and are NOT inspected on-site by the
organization, YOU DO NOT QUALIFY FOR THE MTS ACCREDITED LICENSE
CATEGORY.
HOSPITALS WHERE TESTING IS PERFORMED AT MORE THAN ONE SITE:
In hospitals, all areas of laboratory testing must be covered by a MTS
license. If the main laboratory license does not include the point-of-care
testing that is performed in other areas of the hospital such as on the wards,
in surgery, or in the ER, then these areas must have a separate license. It is
the hospital» s decision how it wants to license these areas, but all
point-of-care areas must be covered by a MTS license.
SIGNATURE:
The application form must be signed by the owner or authorized
representative of the Medical Test Site.
TEST INFORMATION
WAIVED / PPMP TESTS:
If your facility performs any tests classified as waived and uses the
specific test kits listed, please check those tests performed in the
appropriate section of the application. If the
microscopic procedures are performed only by the provider, please check those
tests performed under the PPMP portion of the application only and do not
list them on Page 6 of the application.
To qualify for a Certificate of Waiver, a facility must perform only
tests listed and use the one of the test kits specified that have been categorized as waived
underCLIA.
To qualify for a Provider Performed Microscopic Procedures (PPMP)
license, the microscopic procedures categorized as PPMP Under CLIA
can only be performed by one of the following providers: doctor
of medicine (MD), doctor of osteopathy (DO), doctor of podiatric medicine (DPM),
dentist, advanced registered nurse practitioner (ARNP), nurse midwife,
physician assistant (PA), or naturopath. A PPMP site is also eligible to
perform any of the waived
tests.
If a test site performs any tests or uses test kits other than those
listed in the PPMP or Waived test tables, list the tests on Pages 6-7 of the
license application. In addition, if PPMP tests are being performed on-site by
anyone not on the approved list of providers, list the tests performed
on Page 6 of the application under Microscopic Procedures.
SPECIALTY / SUBSPECIALTY TEST INFORMATION:
Pages 6-7 of the MTS license application form provides specific test
information about the medical test site. Place a check mark by each of the
tests that are performed at your medical test site. If the tests that you
perform are not specifically listed on the checklist, list them under the
appropriate specialty or subspecialty. Include the estimate of numbers of
tests performed YEARLY for each specialty or subspecialty on the line next to
the name of the specialty or subspecialty.
Review the test listing carefully to be sure that you include ALL of the
tests performed at your facility. Tests that are commonly forgotten are:
Infectious Mononucleosis (Infect. Mono. under General Immunology)
NON-WAIVED KITS;
Strep Screens or Rapid Strep Screen (Direct Strep Ag under Bacteriology) NON-WAIVED
KITS; and
Serum Pregnancy Tests (HCG [serum] under Endocrinology).
Remember, if you are performing any testing or are using test kits other
than those that are classified as Waived or PPMP, the test is considered
regulated and must be included on the test list in Pages 6-7 of the license
application.
Include Urinalysis (the dipstick portion) ONLY if a non-waived instrument
is used to read the strip. If you use a waived instrument to read the stick or
read manually, the Urinalysis is considered a Waived test and is
not counted here.
Guidelines for
Counting Tests
- Allergens:
counted as
one test per individual allergen.
- Chemistry
profiles:
each individual analyte is counted separately.
- Complete
blood counts:
each measured individual analyte that is ordered
and reported is counted separately. Differentials
are counted as one test. Manual
differentials are counted as a separate test.
- Cytogenetics:
the number of tests is determined by the number of specimen types processed on
each patient; e.g., a bone marrow and a venous blood specimen received on one
patient is counted as two tests.
- Cytology:
each slide (not case) is counted as one test for both Pap smears and
nongynecologic cytology.
-
Immunohematology:
each ABO, Rh, antibody screen, crossmatch or antibody identification is
counted as one test.
- Histocompatibility:
each HLA typing (including disease associated antigens), HLA antibody screen,
or HLA crossmatch is counted as one test.
- Histopathology:
each block (not slide) is counted as one test.
Autopsy services are not included.
For those laboratories that perform special stains on histology slides,
the test volume is determined by adding the number of special stains performed
on slides to the total number of specimen blocks prepared by the laboratory.
- Microbiology:
susceptibility testing is counted as one test per group of antibiotics used to
determine sensitivity for one organism. Cultures
are counted as one per specimen regardless of the extent of identification,
number of organisms isolated and number of tests/procedures required for
identification.
- Urinalysis:
microscopic and macroscopic examinations each count as one test.
Macroscopies (dipsticks) are counted as one test regardless of the
number of reagent pads on the strip.
PERSONNEL
QUALIFICATION REQUIREMENTS
Complete the appropriate sections of pages 8-9 if you are applying for a
moderate or high complexity testing license (tests listed on pages 6-7 of the
application). If you are unsure whether the tests that you will be doing
are classified as moderate or high, you can access that information at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/search.cfm
or contact the LQA office at (206) 418-5418.
If there are any questions regarding the license process or specific
questions on how to fill out the application, please call the LQA office:
Seattle (Main Office): (206) 418-5600
Mailing Address:
Office of Laboratory Quality Assurance
1610 NE 150th Street
Shoreline, WA 98155
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