Section 1200-06-03-.02 - LICENSING PROCEDURES AND LICENSURE EXEMPTIONS(1) Applications (a) An application for a medical laboratory license shall be made under oath, by the owner and director of the medical laboratory or public official responsible for the operation of a city or county medical laboratory or institution that contains a medical laboratory, upon forms provided by the Board.(b) All laboratories performing tests must file a separate application for each laboratory address.(c) Laboratories within a hospital that are located in contiguous buildings on the same campus and under common direction may file a single application or multiple applications for the laboratory sites within the same physical location or street address.(d) Each application shall include, in alphabetical order, a roster of all personnel currently employed in the laboratory, the classification/category in which the employee functions and is licensed, license number, expiration date and social security number. This shall include all medical laboratory directors, consultants, supervisors and testing personnel.(e) The application will be returned to the applicant if it is incomplete or requires correction.(f) After submission of the completed application, the laboratory or collection station may be issued a letter of temporary license which shall be valid for a period of not longer than three (3) months from the date the application is received by the Board. This temporary license will allow the laboratory to perform testing and allow the collection station to collect specimens until an on-site inspection is conducted and a determination is made whether the laboratory or collection station is in compliance. The laboratory shall be fully operational, including but not limited to the reporting of patient results, at the time of the on-site inspection. The collection station shall be fully operational at the time of the on-site inspection. If the laboratory or collection station is found to be in compliance, it shall be issued a permanent license, provided all other requirements for licensure have been met.(2) License - Issued (a) A license shall be issued authorizing the performance of one (1) or more medical laboratory specialties or subspecialties, the location of testing, the name of the laboratory director and type of ownership.(b) A license shall be issued authorizing the collection of specimens, the location of collection, the name of the physician and type of ownership.(c) A license shall be valid only in the hands of the person or persons to whom it is issued and shall not be the subject of sale, assignment, or transfer, voluntary or involuntary, nor shall a license be valid for any premises other than those for which issued.(d) The license shall be displayed at all times in a prominent place where it may be viewed by the public.(3) Fees - The fees established by the Board pursuant to the Tennessee Medical Laboratory Act (T.C.A. §§ 68-29-101, et seq.) for licensure are as follows: | (a) | Initial Laboratory Application Fee - This fee is nonrefundable. | $1000.00 |
| (b) | Laboratory License Renewal Fee - To be paid annually by all licensees. | $1000.00 |
| (c) | Late Laboratory License or Collection Station Renewal Penalty Fee -To be paid when a licensee fails to timely renew annual license. | $ 500.00 |
| (d) | Annual State Regulatory Fee - To be paid by all licensees. | $ 5.00 |
| (e) | Replacement License (other than 1200-06-03-.03 ) when lost or misplaced. | $ 50.00 |
| (f) | Initial Collection Station Application Fee | $ 700.00 |
| (g) | Collection Station Renewal Fee | $ 700.00 |
| (h) | T.C.A. § 68-29-112 Fee - A nonrefundable fee to be paid when there is a change in laboratory ownership, directorship, or location. | $ 100.00 |
(4) Fees may be paid in the following manner:(a) All fees paid by money order, certified, personal, or corporate check must be submitted to the Board's Administrative Office and made payable to the Tennessee Medical Laboratory Board.(b) Fees may be paid by Division-approved credit cards or other Division-approved electronic methods.(5) Pursuant to T.C.A. § 68-29-104(8) the Board hereby exempts the following laboratories (or portions of otherwise licensed laboratories) and the personnel performing tests in those laboratories (or portions of otherwise licensed laboratories) from the requirements imposed pursuant to the "Tennessee Medical Laboratory Act": (a) Any laboratory (or portion of an otherwise licensed laboratory) which is operated by the Tennessee Department of Health and in which the only testing on human specimens is that which is required pursuant to an investigation ordered by or in cooperation with the State Epidemiologist or law enforcement agency the results of which are reported only to the State Epidemiologist, CDC or law enforcement officials as required by federal law.Tenn. Comp. R. & Regs. 1200-06-03-.02
Original rule filed October 26, 1979; effective December 10, 1979. Amendment filed June 30, 1987; effective August 14, 1987. Amendment filed February 21, 1991; effective April 7, 1991. Repeal and new rule filed January 7, 1997; effective March 23, 1997. Amendment filed August 31, 2001; effective November 14, 2001. Repeal and new rule filed June 18, 2002; effective September 1, 2002. Amendment filed July 8, 2004; effective September 21, 2004. Amendment filed December 27, 2006; effective March 12, 2007. Amendment filed April 17, 2007; effective July 1, 2007. Amendment filed April 1, 2009; effective June 15, 2009.Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-103, 68-29-104, 68-29-105, and 68-29-113.