Tenn. Comp. R. & Regs. 1200-06-03-.16

Current through October 22, 2024

Section 1200-06-03-.16 - ALTERNATE SITE TESTING

(1) Point of Care Laboratory Testing.

(a) Definition: "Point of Care" laboratory testing is laboratory testing performed by health care personnel/professionals not licensed by the Medical Laboratory Act, T.C.A. §§ 68-29-101, et seq., and is performed outside the duly licensed laboratory and under the auspices of a laboratory required to be licensed by the Department, pursuant to the Medical Laboratory Act.

(b) All point of care laboratory testing must be approved by the Board in accordance with the following guidelines.

1. For those tests determined by the Board to be appropriate for safe and accurate performance in a point of care setting (see waived test list) written notification shall be submitted on forms provided by the Board to the Administrative Office of the Board.

2. For all other tests not covered under part 1 of this subparagraph (above), a facility must petition, and appear before the Board and satisfy the Board that approval for point of care testing is appropriate. A facility that has received approval from the Board for instrument/method to be used by identified personnel and/or department(s) for point of care testing of an analyte does not have to appear before the Board again to add analytes to the approved instrument/method and may add them by submitting written notification to the Board's administrative office. It is only when the facility wants to change or add personnel or department(s) to the previously approve instrument/method that another hearing before the Board is required.

3. Requests to perform non-waived point of care tests must be submitted in writing and must include at least:

(i) Statement of medical need for performance outside a laboratory setting.

(ii) Analyte and methodology.

(iii) Personnel authority and responsibility.

(iv) Quality assurance protocols.

(v) Maintenance of records.

(vi) Performance and improvement protocols.

(c) The performance of point of care laboratory testing must comply with the following minimum guidelines:

1. Documentation must show that the method used for testing has been approved by the Medical Laboratory Director.

2. Documentation must show that an adequate training protocol, demonstration of competency, and annual in-service with demonstration of competency for each person performing the testing, has been approved by the Medical Laboratory Director.

3. Records shall be retained for at least two (2) years, which show that manufacturer recommendations regarding the performance of quality control were met. Quality control records shall be reviewed by a person with appropriate authority according to an established performance improvement program.

4. Results of point of care laboratory testing must be recorded in an appropriate clinical record and include the identity of the patient, date and time of specimen collection, units of measurement, test location and identity of the analyst performing the test. Such records must be readily retrievable for inspection.

5. The Medical Laboratory Director, once having established critical values, shall have the discretion to determine if, consistent with good patient care, there is a need for verification by the clinical laboratory when values fall above or below the established critical values.

6. Written policies and procedures, as approved by the Medical Laboratory Director, shall be available in the laboratory and at all locations where point of care laboratory testing is performed. Such procedures shall be appropriate to the personnel and location performing the testing.

(d) Approval to perform point of care laboratory testing may be granted annually provided all minimum guidelines are met. The criteria for withdrawal of approval to perform such testing shall include but not be limited to:

1. Performance of testing by unauthorized personnel.

2. Failure to comply with the above stated guidelines

3. Unsatisfactory performance on two (2) consecutive or two (2) of three (3) consecutive proficiency test surveys.

4. Failure to comply with other State or Federal guidelines.

5. Deficiencies without an acceptable plan of correction cited by the Tennessee Medical Laboratory Board surveyors upon and on-site inspection of the laboratory.

(2) Physician's Office Laboratories - Physician Office Laboratories (POLs) are exempt from licensure requirements of the Medical Laboratory Act

(a) To be eligible for this exemption, the following conditions must be met:

1. The laboratory collects, accepts, and tests only specimens from the private and personal patients of the physician who operates the practice or from the private and personal patients of any physician who is a member of a medical/physician group practice that operates the laboratory regardless of the distance of any member physician's practice location from the group practice's laboratory or the number of specimens collected, accepted, and/or tested; and

2. The laboratory must be operated by the physician or through the employees of the physician. In a medical/physician group practice, one (1) of the group's physicians must be designated to operate the laboratory. The designated physician is responsible for actual supervision and direct responsibility for the performance of the laboratory and its personnel which includes, but is not limited to, actual supervision and direct responsibility for quality assurance, quality control, and test management; and

3. The tests performed in the laboratory are used only for diagnosis and/or treatment of patients of the individual or group practice and are maintained in the practice's medical records for the patients for whom the tests were performed.

(b) In the case of a medical/physician group practice, proof of affiliation with the group practice must be maintained at all offices in which the laboratory is not physically located and produced upon request by an authorized agent of the Department.

(c) Industrial or company physician practices, student health services and other arrangements in which a licensed physician is responsible for the continuing care of a group of patients on an ongoing basis will be designated to be POLs.

(3) Screening Programs - Screening programs are offerings of specified medical laboratory tests to the general public, the purpose of which is educational rather than for diagnosis of disease, and the results of which are immediately available on the site of the program to the person being tested except for those tests which for methodological reasons must be submitted to a medical laboratory in which case they shall be sent to a Tennessee licensed medical laboratory.

(a) Screening programs conducted by for-profit hospitals or nonprofit organizations are exempt from the licensure requirements of the Medical Laboratory Act, pursuant to T.C.A. § 68-29-104(6), when the following conditions are met:

(b) The screening program must be under the direct supervision of a physician licensed in Tennessee. Direct supervision means that a physician will be responsible for quality assurance of the testing performed and review of the results of such testing. The physician is not required to be on site for the screening program event.

(c) The results of the screening program testing must be submitted to the personal physician of the individual being screened or reviewed by the physician responsible for the screening program. During the screening process, the individual being screened must be afforded reasonable privacy and, when required, on-site confidential counseling about the results of the testing.

(d) A written notification to conduct a screening program must be submitted to the Administrative Office for the Medical Laboratory Board, indicating compliance with these rules and providing the following information:

1. Location of testing.

2. Date of testing.

3. Type of tests to be performed and methodology to be used.

4. Name of the licensed physician supervising the screening.

5. Name and address of the for-profit hospital or nonprofit organization conducting the screening.

6. Statement indicating that the testing staff has appropriate training and competency to conduct the testing.

7. Assurance that the for-profit hospital or nonprofit organization is in compliance with Rule 1200-06-03-.11 regarding the handling of infectious and hazardous waste.

(e) A copy of the written notification submitted to the Administrative office must be retained by the for-profit hospital or nonprofit organization conducting the screening program and must be available for inspection at the site of the screening program.

(f) Notification of screening is not required when the for-profit hospital or nonprofit organization is a licensed medical laboratory, provided the laboratory has complied with Rules 1200-06-03-.17 regarding the performance of waived testing and 1200-06-03-.16 regarding point of care testing.

Tenn. Comp. R. & Regs. 1200-06-03-.16

Original rule filed February 14, 2000; effective April 29, 2000. Amendment filed December 1, 2000; effective February 14, 2001. Repeal and new rule filed June 18, 2002; effective September 1, 2002. Amendment filed May 23, 2003; effective August 6, 2003. Amendment filed February 15, 2006; effective May 1, 2006. Amendment filed March 14, 2006; effective May 28, 2006. Amendment filed July 10, 2006; effective September 23, 2006. Amendment filed December 27, 2006; effective March 12, 2007. Amendment filed October 3, 2014; effective 1/1/2015.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-104, and 68-29-105.