Tanner Clinic - Layton

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on direct observation, record review, and interview with the technical supervisor (TS), pipette calibration check was not performed per protocol for the Group B Strep PCR assay performed on the BD Max instrumentation. The laboratory performs approximately 900 Group B Strep tests per year. Findings include: 1. Direct observation on 4/12/23 at approximately 3:10 PM, revealed a calibration check sticker on Fisherbrand Elite 10-100 L pipette with serial number Q419087 which stated calibration was due on 03/2022. 2. Review of the Fisherbrand Elite Pipette Manual revealed that the pipette should be checked every three months. 3. Record review did not include pipette calibration checks for pipette Q419087. 4. In an interview on 4/12 /23 at approximately 3:15 PM, TS1 confirmed pipette Q419087 was utilized for patient testing for the Group B Strep PCR assay when the pipette was past its calibration check due date. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on new lot number verification documentation review, instrument settings review, lack of documentation, and interview with staff, the laboratory failed to follow Sysmex CA600 manufacturer's instructions to perform Innovin reagent new lot number verification using the new lot number of reagent and the new lot number's International Sensitivity Index (ISI) to calculate the normal patient geometric mean. Then use the newly determined geometric mean as the denominator for the calculation of the International Normalized Ratio for coagulation measurement of the Prothrombin time for 1 of 1 new lot number of Innovin received from November 2018 to November 2019 (lot number 549752). The lab performed approximately 8 to 14 INR calculations per day. Findings include: 1. The new lot number verification included the calculation for the new patient mean of 15.5.. The normal patient geometric mean was not obviously stated as such in the verification record 2. Sysmex CA 600 instrument settings observed on 11/18/2020 at approximately 12:00 Noon. Was 10.1, the same as the previous lot number of 10.1455 rounded down. 3. In an interview with staff on 11/18/2020 at approximately 12:45 staff confirmed they could not determine if the new normal patient geometric mean was correctly calculated and entered into the Sysmex CA600 instrument for INR calculation. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on patient test records review, quality control records review, lack of documentation, and interview with staff, the laboratory failed to record the lot number and expiration dates of qualitative serum pregnancy test kits, the dates the kits were placed into use, and the date the kits expired for 2 years of testing reviewed. Findings include: 1. Patient test records review for patient 759865 included a negative qualitative serum pregnancy test. 2. Quality control record review for serum qualitative pregnancy tests performance on 06/01/2019 failed to include the lot number or expiration date of the the test kit in use. 3. In an interview on 11/16/2020 at approximately 6:45 P.M. the laboratory director confirmed serum qualitative pregnancy tests kit lot numbers were not recorded in the test system from November 2018 to November 2020. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on personnel competency evaluations review, lack of documentation, and interview with the technical supervisor, the laboratory failed to evaluate 10 of 10 testing personnel annually for 1 of 2 years of testing reviewed, 2019. Findings include: 1. Personnel records review failed to include competency evaluations for 10 testing personnel performing high complexity testing for more than one year. 2. In an interview conducted on 11/16/2020 at approximately 4:00 P.M. the director confirmed annual competency evaluations were not performed in 2019. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff the laboratory failed to verify the reportable range for Au 680 tests for which the instrument used a two point calibration for 2 of 4 six month time frames after March of 2017 through April 2018 for 8 of approximately 20 tests reviewed. The laboratory performed approximately 800,000 routine chemistry tests per year using the Au 680 instrument. Findings include: 1. Calibration test records reviewed included a two point calibration, as Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- specified by the manufacturer, for Sodium, Potassium, Chloride, Creatinine, Triglycerides, Alanine transaminase, Aspartate transaminase, and Alkaline phosphatase. 2. The laboratory failed to document at least once every 6 months they verified the reportable range of the 8 tests listed in finding 1 at the zero or minimal value, at the mid-level, and at the upper level of the reportable range for each test. 3. In an interview conducted on 04/27/2018 at approximately 4:45 P.M. the laboratory staff stated they did not have documentation they verified the tests reportable range at least once every 6 months of testing in September of 2017 and April of 2018. , -- 2 of 2 --