Enrollment and Testing of Samples - Each laboratory must enroll in a
proficiency testing (PT) program that meets the criteria in 42 CFR Part 493
Subpart I of the current CLIA Regulations and is approved by HHS. The
laboratory must enroll in an approved program for each of the specialties and
subspecialties for which it seeks licensure. The laboratory must test the
samples in the same manner as patient's specimens.
1. The laboratory must ensure that the Board
is notified yearly of the approved program or programs in which it chooses to
participate to meet proficiency testing requirements of this rule.
2. The laboratory must designate the
program(s) to be used for each specialty, subspecialty, and analyte or task to
determine compliance with the rule if the Laboratory participates in more than
one (1) proficiency testing program approved by CMS.
For those tests performed by the
laboratory for which proficiency testing is not required by 42 CFR Part
493.901, Subpart H of the CLIA regulations, a laboratory must establish and
maintain the accuracy and reliability of its testing procedures, in accordance
with Rule 1200-06-03-.10(5)
4. For each specialty, subspecialty and
analyte or test, the laboratory must participate in one (1) approved
proficiency testing program or programs, for one (1) year before designating a
different program and must notify the Board before any change in
5. The laboratory must
authorize the proficiency testing program to release to the Board all data that
may be required to determine the laboratory's compliance with this
Testing of proficiency testing samples. The laboratory must examine or test, as
applicable, the proficiency testing samples it receives from the proficiency
testing program in the same manner as it tests patient specimens.
1. The samples must be examined or tested
with the laboratory's regular patient workload by personnel who routinely
perform the testing in the laboratory, using the laboratory's routine
2. The individual testing
or examining the samples and the laboratory director must attest to the routine
integration of the samples into the patient workload using the laboratory's
3. The laboratory
must test samples the same number of times that it routinely test patient
4. Laboratories that
perform tests on proficiency testing samples must not engage in any
inter-laboratory communications pertaining to the results of proficiency
testing sample(s) until after the date by which the laboratory must report
proficiency testing results to the program for the testing event in which the
samples were sent.
with multiple testing sites or separate locations must not participate in any
communications or discussions across sites/locations concerning proficiency
testing sample results until after the date by which the laboratory must report
proficiency testing results to the program.
6. The laboratory must not send proficiency
testing samples or portions of samples to another laboratory for any analysis
which they are certified to perform in their own laboratory.
Any laboratory that the Board determines
intentionally referred its proficiency testing samples to another laboratory
for analysis and submits the other laboratory's results as their own shall have
its license disciplined, pursuant to Rule
8. Any laboratory that receives proficiency
testing samples from another laboratory for testing must notify the Board of
the receipt of those samples.
The laboratory must document the handling, preparation, processing,
examination, and each step in the testing and reporting of results for all
proficiency testing samples.
The laboratory must maintain copy of all records, including a copy of the
proficiency testing program report forms used by the laboratory to record
proficiency testing results including the attestation statement provided by the
proficiency testing program, signed by the analyst and the laboratory director,
documenting that proficiency testing samples were tested in the same manner as
patient specimens, for a minimum of two (2) years from the date of the
proficiency testing event.
Unless otherwise specified in the Rules, proficiency testing is required for
only the test system, assay, or examination used as the primary method for
patient testing during the proficiency testing event.
(a) Each laboratory performing
tests must successfully participate in a proficiency testing program approved
by CMS, if applicable, for each specialty, subspecialty, and analyte or test in
which the laboratory is certified under CLIA.
If the laboratory fails to participate
successfully in proficiency testing for a given specialty, subspecialty,
analyte or test sanctions will be taken as defined in Rule
Condition: Reinstatement of
Laboratories after Failure to Participate Successfully.
(a) If a laboratory's license is suspended or
placed on probation by the Board or limited pursuant to CLIA regulations
because it fails to participate successfully in proficiency testing for one (1)
or more specialties, subspecialties, analyte, or voluntarily surrenders its
license for the failed specialty, subspecialty, or analyte, the laboratory must
then demonstrate sustained satisfactory performance on two (2) consecutive
proficiency testing events, before the Board will consider it for reinstatement
in that specialty, subspecialty, analyte or test.
(b) The period of suspension of licensure for
the failed specialty, subspecialty, or analyte or test is for a period of not
less than six (6) months from the date of suspension.
If a laboratory's license is suspended,
the laboratory must take corrective action and petition the Board for the
suspension to be lifted and apply for the license to be reinstated and pay any
necessary fees as set out in
Condition: Specialties and
(a) Failure to attain an
overall testing event score of at least eighty per cent (80%) is unsatisfactory
performance for Bacteriology, Mycobacteriology, Mycology, Parasitiology,
Virology, Syphilis Serology, General Immunology, Routine Chemistry,
Endocrinology, Toxicology, Hematology, Antibody Detection, and Anti-Body
(b) Failure to
attain a score of at least eighty per cent (80%) of acceptable responses for
each analyte in each testing event is unsatisfactory analyte performance for
the testing event of General Immunology, Routine Chemistry, Endocrinology,
Toxicology, and Hematology.
Failure to attain an overall testing event score of at least one hundred per
cent (100%) is unsatisfactory performance for ABO grouping, Rh typing, and
to participate in a testing event is unsatisfactory performance and results in
a score of zero (0) for the testing event.
Consideration may be given to those
laboratories failing to participate in a testing event only if the following
requirements are met:
1. Patient testing was
suspended during the time frame allotted for testing and reporting proficiency
testing results; and
laboratory notifies the inspecting agency and the proficiency testing program
within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
3. The laboratory had successfully
participated in the previous two (2) proficiency testing events.
(f) Failure to return proficiency
testing results to the proficiency testing program within the time frame
specified by the program is unsatisfactory performance and results in a score
of zero (0) for the testing event.
(g) For any unsatisfactory analyte or testing
event for reasons other than a failure to participate, the laboratory must
undertake appropriate training and employ the technical assistance necessary to
correct problems associated with a proficiency testing failure.
(h) For any unsatisfactory analyte or testing
event score, remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two (2) years from the
date of participation in the proficiency testing event.
(i) Failure to achieve satisfactory
performance for the same analyte or test in two (2) consecutive testing events
or two (2) out of three (3) consecutive testing events is unsuccessful
(j) Failure to achieve
an overall testing event score of satisfactory performance for two (2)
consecutive testing events or two (2) out of three (3) consecutive testing
events is unsuccessful performance.
(k) All unsuccessful testing events shall be
reported to the Department within thirty (30) days of receipt of the hard copy
print-out that documents results for unsuccessful proficiency
Tenn. Comp. R. &
Original rule filed
October 26, 1979; effective December 10, 1979. Amendment filed December 14,
1981; effective January 28, 1982.Amendment filed September 30, 1987; effective
November 14, 1987. Repeal filed May 3, 1995; effective July 17, 1995. New rule
filed January 7, 1997; effective March 23, 1997. Repeal and new rule filed June
18, 2002; effective September 1, 2002. Amendment filed August 25, 2003;
effective November 8, 2003. Amendment filed October 11, 2004; effective
December 25, 2004.
Authority: T.C.A. §§
68-29-104, and 68-29-105.