Certificate of Waiver Medical Test Site (MTS) Application Packet

DOH 505-038 July 2024

Certicate of Waiver Medical Test Site (MTS)

Application Packet

Contents:

1. 505-038 ....Certicate of Waiver Medical Test Site Application Index and Fee Information

.......................................................................................................................... 1 Page

2. 505-039 ....Certicate of Waiver Medical Test Site Application InstructionsChecklist

.......................................................................................................................... 3 Pages

3. 505-026 ....Certicate of Waiver Medical Test Site Application................................... 7 Pages

Important Information:

Laboratories licensed by the Washington Medical Test Site (MTS) licensure program are exempt from

the Clinical Laboratory Improvement Amendments of 1988 (CLIA). You do not need to apply to the

Centers for Medicare and Medicaid Services (CMS) for a CLIA number. Your MTS license will contain

both your MTS license number and your CLIA number.

If the application you are submitting is handwritten, please ensure the information is written clearly,

accurately, and legibly in order to ensure there is no delay in processing.

In order to process your request:

Return Completed Application (original copy) and fee in the form of check or money order

(made out to Department of Health) to:

Department of Health

P.O. Box 1099

Olympia, WA 98507-1099

Fee Information

Certicate of waiver MTS license applications received during the rst year of the state biennium

(7/01/2023 through 6/30/2024) are required to submit the full fee. Applications received during the

second year of the state biennium (7/01/2024 through 6/30/2025) are required to submit half of the

full fee. The corresponding fees are:

Certicate of waiver

Medical Test Site License Application $260 $130

To request this document in another format, call 1-800-525-0127. Deaf or hard of hearing customers, please call 711

(Washington Relay) or email [email protected].

Fee - Applies to applications

submitted during the rst

y e a r o f t h e b i e n n i u m

7/01/2023-6/30/2024

Fee - Applies to applications

submitted during the second

y e a r o f t h e b i e n n i u m

7/01/2024-6/30/2025

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DOH 505-039 July 2024 Page 1 of 3

When your application for a Medical Test Site is received by the Department of Health,

you will be notied in writing of any outstanding documentation needed to complete the

application process.

All information should be printed clearly in blue or black ink. It is your responsibility to

submit the required forms.

F Indicate type of application:

• New - Choose this option if the facility has never been issued an MTS license.

• Change of ownership - Choose this option if the facility was previously issued an

MTS license and is now under new ownership and/or has a new UBI number.

• Change of license type - Choose this option if the facility has previously

been issued a dierent type of MTS license, such as a Provider Performed

Microscopic Procedure (PPMP) MTS license, a categoried MTS license, or an

accredited MTS license.

F Check One:

Please check your legal owner/operator business structure type according to your

Washington State Master Business License.

F Section 1. Demographic Information:

Unied Business Identier Number (UBI #): Enter your Washington State UBI

#. All Washington State businesses must have a UBI #. City, county, and state

government departments also have UBI #s.

Federal Employer ID Number (FEIN): Enter your FEIN, if the business has been

issued one. If the facility FEIN is dierent than the Legal Owner FEIN, enter this

number on page two of the application under Facility Specic Federal Employer ID

Number (FEIN).

Legal Owner/Operator Entity Name: Enter the owner’s name as it appears on the

UBI/Master Business License.

Legal Owner Mailing Address: Enter the owner’s complete mailing address.

Phone and Fax: Enter the owner’s phone and fax numbers.

Email and Web Address: Enter the owner’s email and facility web addresses, if

applicable.

Facility Name: Enter the lab’s name as advertised on signs and web site.

Facility Specic Federal Employer ID Number (FEIN). Enter if dierent from the

Owner FEIN listed on page one of the application.

Physical Address: Enter the lab’s physical street location including city, state, zip

code, and county.

Certicate of Waiver

Application Instructions Checklist

DOH 505-039 July 2024 Page 2 of 3

Phone and Fax Numbers: Enter the lab’s phone and fax number.

Mailing Address: Enter the lab’s mailing address, if dierent than physical address.

F Section 2. Facility Specic Information:

Site Type: Please check one applicable site type.

Hours of Testing: List the days and hours of testing for this site.

Additional locations under this license: Attach a list of names, addresses and phone

numbers for additional locations, if applicable, and test(s) performed at each site.

F Section 3. Key Individuals:

Lab Director: Enter the lab director’s:

1. First name, last name, and Washington State professional license number, if applicable.

2. Email address.

3. If the director of this laboratory serves as the director for any separately licensed

laboratory, provide the name and CLIA number of the laboratory. Include laboratories

licensed in other states.

Lab Contact: Enter the lab contact’s:

1. First name, last name, and Washington State professional license number, if applicable.

2. Email address.

The lab contact will receive all information that we mail to your medical test site.

F Section 4. Additional Information—Waived Tests:

Fill in the test system and test manufacturer in the provided table for each

test your lab performs. Please verify the waived status of your test system at

https://www.accessdata.fda.gov.

If you perform any non-waived tests, do not complete this application. See the MTS

website to help you determine your correct license category or email the MTS Program at

[email protected].

F Section 5. Other Licensure, Certication, or Registration Information:

Legal Owner: List the names, titles, addresses, and phone numbers of the corporate

ocers, LLC members or manager, partners, etc. Attach additional pages, if necessary.

I n d i c a t e i f y o u w i s h t o r e t a i n t h e C L I A n u m b e r i f s w i t c h i n g t o n e w l i c e n s e t y p e .

Change of Ownership Information: If applicable, list the previous owner name, previous

name of facility, previous MTS license number, eective date of ownership change and

physical address. Indicate if you wish to retain the CLIA number if changing ownership.

F Section 6. Foreign Ownership: Complete if facility is owned fully or partially by foreign

entity.

F Signature:

The legal owner or authorized representative must sign and date the application. Print the

name and title of the legal owner or authorized representative.

You will receive a renewal notice for this license approximately 60 days before the expiration

date. The renewal will be mailed to the facility mailing address on le.

Please contact Facilities Customer Service at 360-236-4985 if you have any questions or

need assistance in completing the application form. Additional information is available on our

website at: https://doh.wa.gov/mts.

DOH 505-039 July 2024 Page 3 of 3

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DOH 505-026 July 2024 Page 1 of 7

Section 1. Demographic Information

Check One

UBI # Federal Employer ID Number (FEIN)

Legal Owner/Operator Entity Name (as it appears on the UBI/Master Business License)

Revenue: 0420030000

Phone (enter 10 digit #) Fax (enter 10 digit #)

Mailing Address

City State Zip Code County

Facility/Agency Name (Business name as advertised on signs or website)

City State Zip Code County

Physical Address

Mailing Address (if dierent than physical address)

Email Address Web Address

Certicate of Waiver Medical Test Site License Application

This is for: F New F Change of Ownership F Change of License Type

F Limited Partnership

F Municipality (City)

F Municipality (County)

F Non-Prot Corporation

F Association

F Corporation

F Limited Liability Company

F Limited Liability Partnership

F Partnership

F Sole Proprietor

F State Government Agency

F Trust

Date

Stamp

Here

Facility Phone (enter 10 digit #) Facility Fax (enter 10 digit #)

City State Zip Code County

P.O. Box 1099

Olympia, WA 98507-1099

360-236-4700

http://www.doh.wa.gov/mts

Medical Test Site # _______________________________CLIA # _____________________________

For Oce Use Only

Facility Specic Federal Employer ID Number (FEIN) (if dierent than one entered above.)

DOH 505-026 July 2024 Page 2 of 7

Section 3. Key Individuals

Lab Director (include MD, PhD, BS, etc. - if applicable. A professional license is not required to be a director for a

waived MTS license)

MTS Contact Person

Email Address

Hours of Testing

Section 2. Facility Specic Information

___ 1 Ambulance

___ 2 Ambulatory Surgery Center

___ 3 Ancillary Test Site

___ 4 Assisted Living Facility

___ 5 Blood Banks

___ 6 Community Clinic

___ 7 Comprehensive Outpatient Rehab

___ 8 End Stage Renal Disease Dialysis

___ 9 Federally Qualied Health Center

___ 10 Health Fair

___ 11 Health Main. Organization

___ 12 Home Health Agency

___ 13 Hospice

___ 14 Hospital

___ 15 Independent Laboratory

___ 16 Industrial

___ 17 Insurance

___ 18 ICFMR

___ 19 Mobile Lab

___ 20 Pharmacy

___ 21 Physician Oce

___ 22 Other ____________________

___ 23 Prison

___ 24 Public Health Lab

___ 25 Rural Health Clinic

___ 26 Student Health Service

___ 27 Skilled Nursing Facility

___ 28 Tissue Bank/Repository

___ 29 Drug Treatment

___ 30 Clinic

___ 31 Adult Family Home

Site Type (check one only)

First Name

If you qualify as a not-for-prot laboratory or state or local government laboratory that performs limited public

health testing (total of 15 or less waived or moderate complexity tests) at dierent locations, you may apply for one

license.

This license will have additional locations under one license and the paragraph above applies: F Yes F No

If yes: Attach a list of names, addresses and phone numbers for each site that will be included under one license,

and a list of tests performed at each site. 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. If you are not a state or local government

laboratory, you must include a copy of your federal 501(c)(3) determination letter to be licensed in this manner.

Additional locations under this license

List days and times during which testing is performed. If testing 24/7 check here F

Sunday Monday Tuesday Wednesday Thursday Friday Saturday

From:

To:

Last Name WA State Professional License number

Does the director of this laboratory serve as director for any other laboratories that are separately licensed in

Washington or another state? F Yes F No

If yes, provide the name of the laboratory and CLIA number:

__________________________________________________________________________________________

First Name Last Name WA State Professional License number

DOH 505-026 July 2024 Page 3 of 7

Section 4. Additional Information—Waived Tests

Complete the table below for waived tests performed by the laboratory. Refer tot he Application Instructions Checklist,

Section 4, if you need assistance completing this table.

Test Name Test System (e.g. One Step Glucose) Test Manufacturer (e.g. ACME)

Adenovirus

Aerobic/Anaerobic Organisms -

Vaginal

Alanine Aminotransferase (ALT)

(SGPT)

Albumin

Albumin, Urinary

Alcohol, Saliva

Alkaline Phosphatase (ALP)

Amines

Amphetamines

Amylase

Aspartate Aminotransferase (AST)

(SGOT)

Bacteria Associated With Bacterial

Vaginosis

Barbiturates

Benzodiazepines

Bilirubin, Total

Bladder Tumor Associated Antigen

B-Type Natriuretic Peptide (BNP)

Buprenorphine

Calcium, Ionized

Calcium, Total

Cannabinoids (THC)

Carbon Dioxide, Total (CO2)

Catalase, Urine

Chlamydia

Chloride

Cholesterol

Cocaine Metabolites

Collagen Type I Crosslink,

N-Telopeptides (NTX)

Cotinine

Creatine Kinase (CK)

Creatinine

Eddp (Methadone Metabolite)

Erythrocyte Sedimentation Rate (ESR),

Nonautomated

Estrone-3 Glucuronide

Ethanol (Alcohol)

Fecal Occult Blood

Fentanyl

Fern Test, Saliva

Waived Tests (continued)

DOH 505-026 July 2024 Page 4 of 7

Follicle Stimulating Hormone (FSH)

Fructosamine

Gamma Glutamyl Transferase (GGT)

Gastric Occult Blood

Gastric pH

Glucose

Glycated Hemoglobin, Total

Glycosylated Hemoglobin (HGB A1C)

hCG, Urine

HDL Cholesterol

Helicobacter Pylori

Helicobacter Pylori Antibodies

Hematocrit

Hemoglobin

Hemoglobin By Copper Sulfate,

Nonautomated

Hepatitis C Virus Antibody

Herpes Simplex I And/Or II Antibodies

HIV-1 And HIV-2 Antibodies

HIV-1 And HIV-2 Antigens

Infectious Mononucleosis Antibodies

(Mono)

Inuenza (A/B)

Ketone, Blood

Ketone, Urine

Lactic Acid (Lactate)

LDL Cholesterol

Lead, Blood

Leukocyte Esterase, Urinary

Lithium

Luteinizing Hormone (LH)

Lyme Disease Antibodies (Borrelia

Burgdorferi Abs)

Matrix Metalloproteinases-9 (MMP-9)

Methadone

Methadone Metabolite (EDDP)

Methamphetamine

Methylenedioxymethamphetamine (MDMA)

Microalbumin

Morphine

Neisseria Gonorrhoeae

Neutrophil Percentage (Neut%)

Nicotine And/Or Metabolites

Nitrite, Urine

Norfentanyl

Nortriptyline

Waived Tests (continued)

DOH 505-026 July 2024 Page 5 of 7

Opiates

Osmolality, Tears

Ovulation Test (LH) By Visual Color

Comparison

Oxazepam

Oxycodone

pH, Urine

Phencyclidine (PCP)

Phenobarbital

Phosphorus

Platelet Aggregation

Platelet Count

Potassium

Pregnanediol Glucuronide

Propoxyphene

Protein, Total

Prothrombin Time (PT)

Red Blood Cell Count (Erythrocyte

Count) (RBC)

Respiratory Bacterial Pathogens

Respiratory Syncytial Virus

Respiratory Viruses

SARS-CoV-2

SARS-CoV-2 And Other Respiratory

Viruses

Secobarbital

Semen

Sodium

Spun Microhematocrit

Streptococcus, Group A

Thyroid Stimulating Hormone (TSH)

Tramadol

Treponema Pallidum (Syphilis)

Antibodies

Trichomonas

Tricyclic Antidepressants

Triglyceride

Urea (BUN)

Uric Acid

Urinary Protein, Qualitative

Urine Dipstick Or Tablet Analytes,

Nonautomated

Urine hCG By Visual Color

Comparison Tests

Urinalysis

Vaginal pH

DOH 505-026 July 2024 Page 6 of 7

Waived Tests (continued)

White Blood Cell Count (Leukocyte

Count) (WBC)

White Blood Cell Dierential (WBC

Di)

Whole Blood Qualitative Dipstick

Glucose

Yeast, Candida Only

Other Waived Test(S) Not Listed

Provide an estimated total annual test volume for all waived tests performed: _________________________________

DOH 505-026 July 2024 Page 7 of 7

Section 5. Other Licensure, Certication or Registration Information

Name Address Phone # Title

Previous Name of Legal Owner

Previous Name of Facility Previous MTS License # Eective Date of Ownership

Change

Physical Address

Legal Owner Information–attach additional sheets as needed

Change of Ownership Information

List names, addresses, phone numbers, and titles of corporate ocers, partners, members, managers, etc.

Signature

I certify that I have received, read, understood, and agree to comply with state law and rule regulating this licensing

category. I also certify that the information herein submitted is true to the best of my knowledge and belief.

___________________________________________________________ _____________________________________

Signature of Owner/Authorized Representative of Medical Test Site Date

___________________________________________________________ _____________________________________

Print Name Print Title

City State

Zip Code

Section 6. Foreign Ownership

Does this facility have partial or full ownership by a foreign entity or foreign government? F Yes F N o

If yes, what is the country of origin for the foreign entity? _______________________________________

If changing license type, do you want the facility to keep the already assigned CLIA number? F Yes F N o

If yes, provide the CLIA number: _______________________________________

If changing ownership, do you want the facility to keep the already assigned CLIA number? F Yes F N o

If yes, provide the CLIA number: _______________________________________