DEPARTMENT OF HEALTH AND HUMAN SERVICESCENTERS FOR MEDICARE & MeDICAID SERVICES

Form ApprovedOMS No. 0938-0S81

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (ellA)APPLICATION FOR CERTIFICATION

I. GENERAL INFORMATION

o Initial Application 0 Survey

o Change in Certification Type

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ellA IDENTIFICATION NUMBER

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(If an initial application leave blank, a number will be assigned)

FACILITY NAME

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FEDERAL TAX IDENTIFICATiON NUMBER

TELEPHONE NO. (Include area code) IFAX NO. (Include area cooe)

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FACILITY ADDRESS - Phys;(i01 Location of Laboratory (Build/nil- Floor, Suiteif applicable.' Fee Coupon/Certificate will be mailed to this Address unlessmailing address is sDecified

MAILING/BILLING ADDRESS (If different from srreet address)

NUMBER, STREET (No P.O. Boxes)

8-lfS fa.11 Ha./( .:5freUCITY ISTATE

Loryjon Oflta.n'o lCar1"-.dCL.NAME OF DIRECTOR (Last;. first, Mfddl~ Initial)

/zIP CODE

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NUMBER. STREET

CITY ISTATE /llP CODE

II. TYPE OF CERTIFICATE REQUESTED (Check only one)

o MBB

o ASHI

DADA

o COLA

o Certificate of Waiver (Complete Sections 1- VI and IX - X)

o Certificate for Provider Performed Microscopy Procedures (PPM) (Complete Sections J- Xl

o Certificate of Compliance (Complete Sections 1- Xj

~Certificate of Accreditation (Complete Sections 1- X) and indicate which of the following organization(s)your laboratory is accredited by for CLIA purposes, or for which you have applied for accreditation forCllA purposes

o The Joint Commission

~CAP

If you are applying for a Certificate of Accreditation, you must provide evidence of accreditation for yourlaboratory by an approved accreditation organization as listed above for ellA purposes or evidence of applicationfor such accreditation within 11 months after receipt of your Certificate of Registration.

NOTE: Laboratory directors performing non·waived testing (inclUding PPM) must meet specific education,training and experience under SUbpart M of the ellA requirements. Proof of these requirements for thelaboratory director must be submitted with the application.

According to the Paperwork Reduction Act of 1995, no person~ are required to respond to a collection of information unless It displays avalid OMB control number. The vaUd OMB control number for this Information collection Is 0938-0581. The time required to complete thisInformation collection is estimated to average 30 minutes to ;Z hours per response, including the time to review instructions, search existingdata resources, gather the data needed, and complete and review the information collection. If you have any comments concerning theaccuracy of the time estimate(s) or suggestions for improving this form, please write to: eMS, Attn: PRA Reports Clearance Officer,7S00 Security Boulevard, Baltimore, Maryland 21244·1850.

Form CMS·116 {lOilOJ

III. TYPE OF LABORATORY (Check the one most descriptive of facility type)

001 Ambulance o 11 Health Main. Organization 022 Practitioner Other (Specify)

002 Ambulatory Surgery Center 012 Home Health Agency

003 Ancillary Testing Site in 013 Hospice 023 PrisonHealth Care Facility 014 Hospital 024 Public Health Laboratories

004 Assisted Living Facility [9'15 Independent 025 Rural Health Clinic005 Blood Bank o 16 Industrial 026 School/Student Health Service006 Community Clinic 017 Insurance 027 Skilled Nursing Facility/007 Camp. Outpatient Rehab Facility o 18 Intermediate Care Facility for Nursing Facility

008 End Stage Renal Disease Mentally Retarded 028 Tissue BanklRepositoriesDialysis Facility 019 Mobile laboratory 029 other (Specify)

009 Federally Qualified 020 PharmacyHealth Center

021 Physician Office010 Health fair Is this a shared lab? 0 Yes 0 No

IV. HOURS OF LABORATORY TESTING (List times during which laboratory testing is performed in HH:MM format)

~~f~Jf~~~ SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAYFROM: 01~oo o I: 00 __Q1.~J2Q ____ __9.2L9_Q____ 01 :00 0, ~OO 07:00

--------------- -----~-r;o6-- -~_q:-o-O----------------~~~ ---------------- :Qq:OO-----TO: ;;).l.{:OO ~L( ~OO ;).1./: 00 .;).Lf ! 00

(For multiple sites, attach the additional information using the same format.)

V. MULTlPLE SITES (must meet one of the regulatory exceptions to apply for this provision)

~':)'ou applying for the multiple site exception?

M No. If no, go to section VI. 0 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 has temporary testing sites?

DYes 0 No

2. Is this a not-for-profit or Federal, State or local government laboratory engaged In limited (not more than a combinationof 15 moderate complexity or waIved tests per certificate) publ ic health testing and fi ling for a single certificate formultiple sites?

DYes 0 No

If yes, provide the number of sites under the certificate and list name, address and test performed for eachsite below.

3. Is this a hospital with several laboratories located at contiguous buildings on the same campus within the same physicallocation or street address and l.Inder common direction that is filing for a single certificate for these locations?

DYes 0 No

If yes, provide the number of sites under this certificate and list name or department, location withinhospital and specialty/subspecialty areas performed at each site below.

If additional space is needed, check here 0 and attach the additional information using the same format.

NAME AND ADDRESS/LOCATION TESTS PERFORMED/SPEOAlTVISUBSPECIALTYNAME OF LABORATORY OR HOSPITAL DEPARTMENT

ADDRESSIlOCATION (Number, Street Location if applicable)

CtTY, STATE, ZIP CODe TELEPHONE NO. (Include area code)

NAME OF LABORATORY OR HOSPITAL DEPARTMENT

ADDRESS/LOCATION (Number, Street,. Location if applicable). - -- - _.

CITY, STATE, lIP CODE TELEPHONE NO. (Include area code)

Form eMS-116 (10110) 2

In the next three sections, indicate testing performed and annual test volume.

VI. WAIVED TESTINGIdentify the waived testing performed. Be as specific as possible. This includes each analyte test system or device used inthe laboratory.

e.g. (Rapid Strep, Acme Home Glucose Meter)

Indfate the estimated TOTAL ANNUAL TEST volume for all waived tests performed

IYr Check if no waived tests are performed

VII. PPM TESTINGIdentify the PPM testing performed. Be as specific as possible.

e.g. (Potassium Hydroxide (KOH) Preps, Urine Sediment Examinations)

Indicate the estimated TOTAL ANNUAL TEST volume for all PPM tests performed _

For laboratories applying for certificate of compliance or certificate of accreditation, also include PPM test volume in the~o)til estimated test volume" in section VIII.[:Yf Check if no PPM tests are performed

If additional space is needed, check here 0 and attach additional information using the same format.

VIII. NON-WAIVED TESTING (Including PPM testing)

If you perform testing other than or in addition to waived tests, complete the information below. If applying for onecertificate for mUltiple sites, the total volume should include testing for ALL sites.

Place a check (/) in the box preceding each specialty/subspecialty in which the laboratory performs testing. Enter theestimated annual test volume for each specialty. 00 not include testing not subject to ellA, waived tests, or tests run for qualitycontrol, calculations, quality assurance or proficiency testing when calculating test volume. (For additional guidance on countingtest volume. see the information included with the application package.)

If applying for a Certificate of Accreditation, indicate the name of the Accreditation Organization beside the applicable specialty/subspecialty for which you are accredited for ellA compliance. (The Joint Commission, AOA, AABB, CAP, COI..A or ASH!)

o Bacteriology

o Mycobacteriology

DMycology

o Parasitology

o Virology

~P1~~fJ.e:,~o Syphilis Serology

~General Immunology

~~~Jl~outine

~Urinalysis

IitEndocrinolo9Y

~Toxico[ogy

Form CM5·116 (10110) 3

IX. TYPE OF CONTROL

VOLUNTARY NONPROFIT

o 01 Religious Affiliation

o 02 Private Nonprofit

D 03 Other Nonprofit

(Specify)

FOR PROFIT

~4 Proprietary

GOVERNMENT

o 05 City

o 06 County

o 07 State

o 08 Federal

o 09 Other Government

(Specify)

X. DIREcrOR AFFIUATION WITH OTHER LABORATORIES

If the director of this laboratory serves as director for additional laboratories that are separately certified, pleasecomplete the following:

CUA NUMBER NAME OF LABORATORY

ATTENTION: READ THE FOLLOWING CAREFULLY BEFORE SIGNING APPLICATION

Any person who intentionaUy violates any requirement of section 353 of the Public Health Service Act asamended or any regulation promulgated thereunder shall be imprisoned for not more than 1 year or finedunder title 18, United States Code or both, except that if the conviction is for a second or subsequent violationof such a reqUirement such person shall be imprisoned for not more than 3 years or fined in accordance withtitle 18, United States Code or both.

Consent: The applicant hereby agrees that such laboratory identified herein will be operated in accordance withapplicable standards found necessary by the Secretary of Health and Human Services to carry out the purposesof section 353 of the Public Health Service Act as amended. The applicant further agrees to permit the Secretary,or any Federal officer or employee duly designated by the Secretary, to inspect the laboratory and its operationsand its pertinent records at any reasonable time and to furnish any requested information or materials necessaryto determine the laboratory's eligibility or continued eligibility for its certificate or continued compliance withellA requirements.

SIGNATURE OF OWNER/DIRECTOR OF lABORATORY (Sign In ink)

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Form CMS-116 (10110)

DATE

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