MEDICAL LABORATORIES SUBJECT TO INSPECTION
Present law authorizes the medical laboratory board ("board") to require the inspection of the premises and operations of all medical laboratories subject to licensure under the Tennessee Medical Laboratory Act ("act"), for the purpose of studying and evaluating the operation, supervision, and procedures of the facilities, and to determine their effect on the health and safety of the people of this state. For this purpose, authorized personnel of the department of health ("department") have the right to enter upon such premises during working hours. A person obstructing such entry violates the act.
This bill clarifies that a hospital-based laboratory is not required to obtain a separate license for each location it maintains as long as the off-site laboratory maintains at least one of the following pursuant to an inspection conducted by an organization described under the heading "Permissible Inspectors," below: (i) an active CLIA license, (ii) an active certificate of registration, (iii) an active certificate of compliance, or (iv) a certificate of accreditation.
PERMISSIBLE INSPECTORS
This bill authorizes a hospital-based laboratory to be inspected by the health facilities commission, the joint commission on accreditation of health care organizations, Det Norske Veritas, or another organization that is authorized to inspect laboratories for medicare enrollment purposes by the U.S. department of health and human services.
LICENSE REQUIRED TO OPERATE MEDICAL LABORATORY AND NUMBER OF LABORATORIES A PERSON MAY DIRECT
Present law prohibits a person from conducting, maintaining, or operating a medical laboratory in this state unless a license has been obtained from the board, except laboratories exempt under state law. Unless specifically authorized by the board, present law prohibits an individual from directing more than one medical laboratory. A separate license must be obtained for each location.
This bill clarifies that a person is prohibited from conducting, maintaining, or operating a hospital-based laboratory in this state without a license from the board. The bill prohibits an individual from directing more than one hospital-based laboratory.
This bill authorizes a hospital-based laboratory supervisor to supervise more than one hospital medical laboratory when the hospital-based laboratories are located within hospitals designated as rural hospitals by the board. A hospital-based laboratory supervisor may supervise up to four separate rural hospital laboratories.
This bill authorizes a hospital-based laboratory supervisor to supervise technical personnel, perform tests requiring special scientific skills, and in the absence of the medical laboratory director, be responsible for the proper performance of all medical laboratory procedures and the reporting of results.
For purposes of this bill, a "hospital-based laboratory supervisor" means a professional licensed by the board who:
(1) Possesses a minimum of an associate's degree in medical laboratory science, biology, chemistry, or a related field from an accredited institution, or has at least two years of equivalent practical experience as determined by the board;
(2) Has completed a federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) training module and a state training module as approved by the board; and
(3) Works under the general supervision of a medical laboratory director as described in the act.
LICENSES REQUIRED FOR MEDICAL LABORATORY PERSONNEL AND SUPERVISION OF EMPLOYEES
Present law prohibits a person from acting as a medical laboratory director, supervisor, technologist, technician, laboratory trainee or special analyst and accepting a specimen for laboratory examination, unless such person has obtained a license and is registered to act in such capacity by the board. This bill applies this prohibition to hospital-based laboratory supervisors.
Present law requires persons who collect specimens or report the results of an examination to be under the supervision of a licensed medical laboratory director, medical laboratory supervisor, or medical laboratory technologist or other persons so designated by the regulations promulgated under the act. This bill adds a hospital-based laboratory supervisor to the list of possible supervisors.
ON APRIL 1, 2024, THE SENATE ADOPTED AMENDMENT #1 AND PASSED SENATE BILL 2230, AS AMENDED.
AMENDMENT #1 rewrites the bill to, instead, do the following:
(1) Establish that a "rural hospital-based laboratory" means a medical laboratory located within a rural hospital licensed in this state that primarily provides testing services to patients of the hospital, including, but not limited to, patients in emergency, inpatient, and outpatient settings;
(2) Require a rural hospital-based laboratory to maintain, in addition to a license issued by the board, at least (i) an active Clinical Laboratory Improvement Amendments of 1988 (CLIA) license that includes a certificate of accreditation from an approved accrediting organization recognized under CLIA or by the applicable state agency with designated authority to grant CLIA certification; (ii) an active certificate of registration; (iii) an active certificate of compliance; or (iv) a certificate of hospital accreditation as described in (3) below;
(3) Authorize hospital accreditation to be obtained from the health facilities commission, the department of health, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), DNV Healthcare, or another organization that is authorized to survey hospitals for medicare enrollment purposes by the United States department of health and human services to comply with a condition of participation in the medicare program in accordance with current requirements of the medicare program;
(4) Prohibit a person from conducting, maintaining, or operating a rural hospital-based laboratory in this state unless a license has been obtained as described in the bill, except for laboratories exempt under the Tennessee Medical Laboratory Act;
(5) Consistent with federal requirements, authorize a medical laboratory supervisor to supervise up to five separate rural hospital-based medical laboratories when the rural hospital-based laboratories are located within hospitals designated as rural hospitals in accordance with the current federal health resources and services administration's definition of rural areas; and
(6) Prohibit a medical laboratory director from directing more than five rural hospital-based laboratories, consistent with federal requirements.

Statutes affected:
Introduced: 68-29-103, 68-29-106, 68-29-111, 68-29-116(a), 68-29-116, 68-29-116(b)