1-833-4CA4ALL Email a scanned copy of the forms or any questions to: PO Box 997377 Use this button to show and access all levels. To change the address, mailing address, phone or fax,email, facility name and/or tax ID The of type license you need depends on the type of testing that you perform in your office. You may complete a Credential Status Change Form. Get email alerts based on your topic preferences like news releases, job openings, emergency updates and more! For more information about clinical laboratory licensure in Massachusetts, please see the frequently asked questions about clinical laboratory state licensure page. The change(s) being made - old information, new information and effective date of the change; Signature of the Laboratory Director or his/her designee (someone with the authority to make changes) In lieu of written notification, a new form CMS 116 CLIA Application is also acceptable. CLIA Form CMS-116 required unless accredited. Proudly founded in 1681 as a place of tolerance and freedom. Permit and With the 2016 Annual report and going forward, the all reporting agencies must contact the Pennsylvania State Police Bureau of Forensic Services via email at: ) or https:// means youve safely connected to the official website. Q7: Does a laboratory director need to be present in the laboratory every day?A7: The regulation at 28 Pa. Code 5.22(g) requires that a director be present for a reasonable period of each working day in each laboratory for which they are a director. Forms and Resources - Tennessee State Government - TN.gov A check or money order for $100, payable to the "Pennsylvania Department of Health;". A bill of sale or other legal document that shows both parties agreement to the sale. The CLIA Application for Certification can be found on the CMS website Street Address City, County, State. Form # CMS 116. Visit the HHSC Clinical Laboratory Improvement Amendment (CLIA) webpage for information on CLIA. For Change of Ownership, in addition to the CMS-116 form you must submit the CLIA Ownership Information form. If you need assistance, please contact the Division of Health Care Facility Licensure and Certification. Laboratory Emergency after hours number: (502) 320-4501, Epidemiology after-hours number: (888) 9REPORT, (888) 973-7678, CLIA Licensure Information: (502)564-7963 ext. The agency has given compliance inspections and management of application information to state health departments. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Make checks payable to the Texas Health and Human Services Commission. However, we must receive the license fee and documentation of enrollment in proficiency testing before we issue the license. This service reduces turnaround time, decreases risks for clerical errors and conveniently allows submission of test orders and retrieval of results. Categorized and Accredited licenses: Since the license fee is based upon the number of specialties and tests performed, we'll send you a bill for the license fee after we process the initial application. Division of Health Care Facility Licensure and Certification, frequently asked questions about clinical laboratory state licensure, Clinical Laboratory License Information Form, Clinical Laboratory Disclosure of Ownership Interest Statement, List of Laboratory Tests Performed Onsite, Temporary Laboratory License for CLIA-waived COVID-19 Testing and Clinical Laboratory Alternate Sites, Application Form for Temporary Laboratory License for CLIA-waived COVID-19 Testing, List of Approved Proficiency Testing Programs, Subscribe to the DPH Clinical Laboratory Listserv, Clinical Laboratory Program laws, regulations, and circular letters, Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate, contact the Division of Health Care Facility Licensure and Certification. Mass.gov is a registered service mark of the Commonwealth of Massachusetts. here. In addition, the individual must have had two years' experience in a laboratory acceptable to DOH or be certified by the American Board of Pathology, American Osteopathic Board of Pathology, American Board of Microbiology, American Board of Bioanalysis, American Board of Clinical Chemistry, or other national accrediting board in laboratory specialties acceptable to DOH. Survey Checklist. Changes to Current Certificates | New York State Department of Health If you're just performing lab testing on Washington residents at your out-of-state laboratory, you don't need an MTS license. An applicant for an initial license must complete the following requirements. CLIA Certificate?A5: An individual serving as a director of a clinical laboratory must hold a doctor of science degree or its equivalent in the basic sciences of chemistry, biology or microbiology or a doctoral degree in public health, medicine, osteopathy, pharmacy, dentistry, or veterinary medicine from a college or university recognized by the National Committee of Regional Accrediting Agencies or the Pennsylvania Department of Education. Persons with a disability who require an alternate format of this notice (for example, large print, audiotape, Braille) should contact Dr. Lute at the Department of Health, Bureau of Laboratories 110 Pickering Way, Exton, PA 19341-1310, 610-280-3464. purchase tests, but, all COVID-19 tests must be Get the Right Results (CDC), To Test or Not to Test Booklet - Considerations for Waived Testing (CDC), How to Obtain a CLIA Certificate of Waiver (CMS), Grant Accountability and Transparency (GATA). The Pennsylvania Department of Health developed reporting forms previously used will no longer be required. PA Clinical Laboratory Permit Application, Understanding Clinical Laboratory Regulations in Pennsylvania, Pennsylvania's regulations governing Clinical Laboratories, Dr. Debra L. Bogen, Acting Secretary of Health, Certificate of Waiver laboratories performing only waived tests, Certificate of Provider-Performed Microscopy Procedures laboratories performing limited provider-performed microscopy procedures, Certificate of Compliance laboratories performing nonwaived or moderate and/or high complexity tests. For a change of ownership you must complete the Change of Ownership Packet. Before sharing sensitive information, make sure youre on an official government site. Marlborough, MA 01752. Form 3210, Ambulatory Surgical Center License Application. Facilities in Washington state that perform tests on materials derived from the human body for the purposes of health care, treatment, or screening are required by law to obtain a Washington Medical Test Site license. If this is a Change of Ownership provide an effective date _ _____ Facility Name (Print) _ . See 35 P.S. All reporting agencies should register with the new Act 27 reporting process by sending an email to the following email address: Articles of Incorporation or Partnership approved by the Massachusetts Secretary of State; Foreign Certificate of Approval signed by the Massachusetts Secretary of State, if the organization is not registered in Massachusetts, Limited license(Moderate complexity testing). A laboratory that is already licensed and wishes to add a specialty or subspecialty must notify and obtain approval from DPH before starting testing. This page is located more than 3 levels deep within a topic. A completed Form 3210 approximately 30 calendar days before the projected opening date of the facility. No, if you're only doing pre-employment drug screens and no other laboratory testing (including waived tests), you do not need an MTS license. Your phlebotomists must have a Washington State professional license, such as registered nurse, licensed practical nurse, physician, medical assistant, etc. Form Approved . CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION . See 35 P.S. Do I need a CLIA certificate? Facilities are required to notify our office of any changes to your CLIA certification within 30 days of the change. How to Complete a Change of Ownership (CHOW) for CLIA no additional fees for Laboratory Director changes effective We are unable to process incomplete application packets. PDF Clinical Laboratory Improvement Amendments (Clia) P.O. Texas Health and Human Services Commission must approve all required application materials received before HHSC will issue a license to the applicant. Reset Check the category of license applying for, or which the laboratory currently holds, as indicated on page 1 of the application: Please pay in the form of a check or money order, payable to the Commonwealth of Massachusetts. Attend a pre-licensure conference (previously called pre-survey conference) conducted by the Health Facility Compliance unit. How can I do that? Texas Health & Human Services Commission. If you're performing the actual testing in Washington State, then you do need to have an MTS license. Records, files, and other documents relating to that temporary testing site are kept at the primary site of the laboratory or the laboratory's home base. In addition, the CLIA-certified facility must apply for a permit to conduct screenings at the site. On July 10, 2015, Governor Wolf signed Act 27 which amended the Sexual Assault Testing and Evidence Collection Act (Act), 35 P.S. CMS-116 CLIA Disclosure of Ownership & Control Interest Statement (Form 1513) Instructions for Completing Disclosure of Ownership and Control Interest Statement (Form 1513) ONLINE SUPPLEMENTAL FORMS (To be used only as directed when applying online via the online licensing system) However, if the laboratory has been approved to perform COVID-19 testing using a CLIA-waived test and wants to add testing that is moderate or high complexity, a Change of Status Form Below is an example of ownership structure. We only accept checks or money orders. A Washington state applicant. Some forms cannot be viewed in a web browser and must be opened in Adobe Acrobat Reader on your desktop system. Please limit your input to 500 characters. INSTRUCTIONS FOR COMPLETING THE CHANGE OF STATUS FORM Please provide only the information that is changing along with the current test menu. For Health Care Regulation contact information, visit the Health Care Facilities Regulation Contact Us webpage. (If yes, list corporation name, address and EIN) Yes No Name: EIN: Address: Attestation Statement: 10172.3(d). Other Changes (Specify) Effective Date . DOC Disclosure of Ownership and Control Interest Statement Newborn screening reports are now available via the KOG Newborn Screen Reports Portal. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) FORMS. RA-DHPACLIA@pa.gov. Effective Jan 1, 2017, the PSP Bureau of Forensic Services (BFS) will be collecting and collating the data from Pennsylvania Law Enforcement agencies and testing laboratories through an online electronic survey system (SurveyMonkey). That laboratory would need to agree to have technical oversight and assume liability for the testing performed at a temporary testing site. form cms-116 (12/21) 1 department of health and human services centers for medicare & medicaid services form approved omb no. Note: If you don't want to be accredited and inspected by a private accreditation organization, complete the categorized MTS application. CMS 209 - Laboratory Personnel Report. CLIA fees vary depending on the type of certificate and/or the annual volume of testing performed. The objective of the CLIA program is to ensure quality laboratory testing. 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