Point of Care
(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
All point of
care laboratory testing must be approved by the Board in accordance with the
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
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.
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
Maintenance of records.
Performance and improvement protocols.
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
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.
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
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.
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.
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:
of testing by unauthorized personnel.
2. Failure to comply with the above stated
performance on two (2) consecutive or two (2) of three (3) consecutive
proficiency test surveys.
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.
Physician's Office Laboratories -
Physician Office Laboratories (POLs) are exempt from licensure requirements of
the Medical Laboratory Act
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;
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
(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.
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. §
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.
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.
Assurance that the for-profit hospital or
nonprofit organization is in compliance with Rule
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.
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
performance of waived testing and
of care testing.
Tenn. Comp. R. &
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
Authority: T.C.A. §§