Section 1200-06-03-.07 - PARTICIPATION IN PROFICIENCY TESTING(1) Condition: 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. (a) Standard Enrollment. 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.3. 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 designation.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 rule.(b) Standard: 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 methods.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 routine methods.3. The laboratory must test samples the same number of times that it routinely test patient samples.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.5. Laboratories 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.7. 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 1200-06-03-.05.8. Any laboratory that receives proficiency testing samples from another laboratory for testing must notify the Board of the receipt of those samples.9. The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples.10. 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.11. 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.(2) Condition: Successful Participation:(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.(b) 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 1200-06-03-.05.(3) 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.(c) 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 1200-06-03-.02.(4) Condition: Specialties and Subspecialties.(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 Identification.(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.(c) 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 Compatibility testing.(d) Failure to participate in a testing event is unsatisfactory performance and results in a score of zero (0) for the testing event.(e) 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; and2. The 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; and3. 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 performance.(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 testing.Tenn. Comp. R. & Regs. 1200-06-03-.07
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. §§ 4-5-202, 4-5-204, 68-29-104, and 68-29-105.