West Tennessee Healthcare Henry County Dba West Tn

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory quality control records, lack of records, and staff interviews the laboratory failed to retain manufacturer quality control (QC) package inserts for the DXH instrument used for complete blood count (CBC) and QC ranges provided by TOSOH for the TOSOH AIA 900 instrument used for patient chemistry and endocrinology testing for two years in 2023 and 2024. The findings include: 1. Observation of the laboratory on 06/14/2024 at 9: 30 am revealed a Beckman Coulter DXH 500 instrument (Serial # BD050395) used for CBC patient testing and a TOSOH AIA 900 instrument (Serial #10895907) for chemistry and endocrinology patient testing. 2. A review of the laboratory's quality control records revealed the following: CBC control lots 352315311, 362315312, 372315313 used on 10/23/2023; CBC control lots 352415911, 362415912, 372415913 used on 04/25/2024. Chemistry/Endocrinology controls for the TOSOH AIA 900 TOSOH Vitamin D Control lot 124B761 used on 10/23/2023. 3. The laboratory was unable to provide the following: Manufacturer QC package inserts for the Coulter DXH lots 352315311, 362315312, 372315313, 352415911, 362415912, 372415913. Manufacturer QC ranges provided by TOSOH for Vitamin D for lot 124B761. 4. An interview on 06/14/2024 at 3:00 pm with the technical consultant confirmed the survey findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer package inserts, laboratory policy, and staff interviews, the laboratory failed to define temperature ranges that were consistent with manufacturer requirements for frozen storage of BioRad quality control (QC) materials used on the TOSOH AIA 900 instrument in 2023 and 2024. This resulted in the BioRad QC material being stored in a way that did not meet the manufacturer's requirements. The findings include: 1. Observation of the laboratory on 06/14/2024 at 9:30 am revealed a freezer used to store aliquots of the BioRad QC (Lyphocheck Immunoassay Plus Control) for the TOSOH AIA 900 instrument (Serial #10895907) used for performing chemistry and endocrinology testing. 2. A review of the manufacturer's package inserts for the BioRad QC Lyphocheck Immunoassay Plus Control revealed the storage requirements were -20 degrees () Celsius (C) to -70C when stored frozen. 3. A review of the laboratory policy titled " Quality Control" section "QC Material Storage and Stability" revealed reconstituted aliquots of QC were stored at -10C to -20C. 4. The survey findings were confirmed in an interview with the technical consultant and testing person one on 06 /14/2024 at 1:00 pm. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interview the laboratory failed to label coplin jars that were used to stain patient slides for manual differential in 2023 and 2024. The findings include: 1. Observation of the laboratory on 06/14/2024 at 9: 30 am revealed four coplin jars on the counter. The jars were not labeled with identity, preparation date, expiration date, or strorage requirements. During the observation testing person one and the technical consultant stated the coplin jars contained stain poured from primary containers and were used to stain patient slides for manual differential. 2. An interview on 06/14/2024 at 3:00 pm with the technical consultant confirmed the survey findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 3 -- 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 observation of the laboratory and staff interview the laboratory used QuickLink III Solution II stain after the manufacturer expiration date in 2023 and 2024. The findings include: 1. Observation of the laboratory on 06/14/2024 at 9:30 am revealed QuickLink III Solution II stain (lot #1343) stored in the laboratory with an expiration date of 10/18/2023. During the observation testing person one and the technical consultant stated the expired Solution II was used to stain patient slides for manual differential. 2. An interview on 06/14/2024 at 3:00 pm with the technical consultant confirmed the laboratory used expired Solution II in 2023 and 2024. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, employee personnel records for 2021 and 2022 and the competency assessment form, and interview with the laboratory supervisor, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency and failed to include re-assessment of competency when test methodology changes. The findings include: 1) Review of the laboratory procedure manual revealed the procedure for assessing testing personnel competency did not include evaluation of problem solving skills, monitoring the recording and reporting of test results, review of intermediate test results or worksheets and maintenance records, and did not require re-evaluation of competency when test methodology changes. 2) Review of the 2021 and 2022 testing personnel records and the form used for documenting competency revealed no documentation of, or a process in place, that included blind testing, record review, monitoring of recording and reporting of test results or problem solving skills to be included in competency assessment evaluations. 3) Interview on 03/06/23 at 4:15 p.m. with the laboratory supervisor confirmed the testing personnel competency procedure did not include all six required criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS) and did not include re- assessment of competency when test methods change. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of control manufacturer instructions for use, and interview with the laboratory supervisor, the laboratory failed to label nine of nine controls observed on the date of the survey (03/06/23) with corrected expiration date after the controls were opened or prepared. The findings include: 1. Observation of the laboratory on 03/06/23 at 8:15 a.m. revealed multiple controls in use for performing quality control on the Beckman Coulter DxH520 complete blood count (CBC) instrument (three levels), the Ortho Vitros 350 chemistry instrument (two levels) and the Tosoh A1A900 chemistry/endocrinology instrument - immunoassay-two levels and vitamin D-two levels. All nine controls were labeled with an open date but no corrected expiration date. 2. Review of the control manufacturer package inserts revealed the following: CBC controls for the Coulter DxH520 are to be stored at 2-8 degrees Celsius (C) and are good for 16 days after opening. Performance Verifier I and II used on the Orthos Vitros 350 chemistry instrument as follows: When stored at 2-8 degrees C: Reconstituted Stability 7 days; "Stable for 3 days: ALKP, ALKP(XT), ALT2, ALT2(XT), ALTJ, ASTJ(XT), BuBc, Ca, Ca(XT), CK, TBIL, TBIL (XT)." Immunoassay Plus used on the Tosoh A1A900 instrument for general chemistry and endocrinology quality control revealed the following: "After reconstituting and storing tightly capped at 2 to 8 degrees (C), this product will be stable as follows: -All analytes: 7 days Except -Folate and PSA (Total): 3 days Vitamin D control used on the Tosoh A1A900 revealed the following: The reconstituted control is stable for 1 day at 18-25 degrees C, 14 days at 2-8 degrees C, and 60 days at -20 degrees C. 3. Interview with the laboratory supervisor on 03/06 /23 at 4:15 pm confirmed the laboratory controls in use had expiration dates that changed after opening or reconstitution and the laboratory failed to label the controls with the corrected expiration dates on the date of the survey (03/06/23) for nine of nine controls observed. 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 -- 2 of 3 -- 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 review of the manufacturer instructions for use, calibration verification records and interview with the laboratory supervisor, the laboratory failed to perform calibration verification for the Prostate Specific Antigen (PSA) at least every six months in 2021 for two of six calibration verification records reviewed. The findings include: 1. Review of the manufacturer instructions for use for PSA performed on the Tosoh A1A900 revealed that calibration is performed using two points. 2. Review of calibration verification records revealed that calibration verification for the PSA was not performed at least every six months in 2021 as follows: Calibration verification was performed August 25, 2020 and was not performed again until March 22, 2021 (six month requirement not met). Calibration verification was performed March 22, 2021 and was not performed again until November 19, 2021 (six month requirement not met) 3. Interview with the laboratory supervisor on 03/06/23 at 4:15 p.m. confirmed the laboratory failed to performed calibration verification for the PSA analyte at least every six months in 2021 (two of six calibration verification records reviewed.) D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of a patient report, lack of documentation and interview with the laboratory supervisor, the laboratory failed to compare results between the automated White Blood Cell (WBC) differential and the manual WBC differential in 2021, 2022 and 2023. The findings include: 1. Observation of the laboratory on 03/06/23 at 8:15 a.m. revealed a Beckman Coulter DxH 520 instrument on the counter in use for performing patient testing for CBC with automated WBC differential and a microscope used for performing manual WBC differentials. 2. Review of patient 62172 performed on 02/02/23 revealed both an automated WBC differential and a manual WBC differential performed on the same patient. 3. There was no documentation of comparison studies to evaluate the results obtained between the automated WBC differential and the manual WBC differential from 2021, 2022 and 2023. 3. Interview with the laboratory supervisor on 03/06/23 at 4:15 p.m. confirmed the laboratory did not perform comparisons between the automated WBC differential and the manual WBC differential in 2021, 2022, and 2023. -- 3 of 3 --