Trinity Valley Diagnostic Clinic

Summary Statement of Deficiencies D0000 An onsite validation survey conducted on 1/11/2024 and 1/12/2024 found the laboratory out of compliance with 42 CFR Part 493, Requirements for Laboratories, for the following conditions: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; 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 CMS (Centers for Medicare and Medicaid Services)-209 form, laboratory policies, competency assessments, and confirmed in interview, the laboratory failed to have documentation of a policy to address competency assessments for 1 of 1 technical consultant (TC-1) and 3 of 3 testing personnel (TP) in 2022 and 2023. Findings Included: 1. Review of CMS-209 form submitted at time of survey, revealed one technical consultant (TC-1) and three testing personnel (TP-1, TP-2 and TP-3) providing services to the laboratory. 2. Review of laboratory policies revealed no documentation of a policy to address competency assessment performance of individuals in the TC and TP laboratory roles in 2022 and 2023. 3. Review of laboratory competency assessments revealed no annual competency documentation for TC-1 in 2022 and 2023. Further review revealed TC-1 did not perform TP-1, TP-2 and TP-3 competencies in 2022 and 2023. Refer to D6046. 4. In an interview on 01/11/2024 at 01:43 p.m., TP-1 confirmed the laboratory failed to have documentation of a policy to address competency assessments for 1 of 1 technical consultant (TC-1) and 3 of 3 testing personnel (TP) in 2022 and 2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory PT (proficiency testing) documentation in 2022 and 2023, and confirmed in interview, the laboratory failed to evaluate and document proficiency testing performances in Hematology and Coagulation that were not evaluated or scored by a CMS-approved PT program for 3 of 5 events in 2022 and 2023. Findings Included: 1. Review of the laboratory American Proficiency Institute (API) PT event documentation for 2022 and 2023 revealed the following analytes /methods that were not evaluated or scored by API: a. 2022 Hematology / Coagulation 2nd Event Analyte / Method: Basophil (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Eosinophil (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Lymphocyte (DIF) (%)^ Sample - Performance DIF- 02 - Not Graded Analyte / Method: Monocyte (DIF) (%)^ Sample - Performance DIF- 02 - Not Graded Analyte / Method: Neutrophil, seg or band (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: NRBC/100 WBC (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Platelet estimate (DIF) ^ Sample - Performance DIF-01 - Not Graded Analyte / Method: Blood Cell ID (Educational) Sample - Performance ECI-06 - Not Graded ECI-07 - Not Graded ECI- 08 - Not Graded ECI-09 - Not Graded ECI-10 - Not Graded b. 2022 Hematology / Coagulation 3rd Event Analyte / Method: Basophil (DIF) (%)^ Sample - Performance DIF-03 - Not Graded Analyte / Method: Eosinophil (DIF) (%)^ Sample - Performance DIF-03 - Not Graded Analyte / Method: Lymphocyte (DIF) (%)^ Sample - Performance DIF-03 - Not Graded Analyte / Method: Monocyte (DIF) (%)^ Sample - Performance DIF-03 - Not Graded Analyte / Method: Neutrophil, seg or band (DIF) (%)^ Sample - Performance DIF-03 - Not Graded Analyte / Method: NRBC/100 WBC (DIF) (%)^ Sample - Performance DIF-03 - Not Graded Analyte / Method: Blood Cell ID (Educational) Sample - Performance ECI-11 - Not Graded ECI-12 - Not Graded ECI-13 - Not Graded ECI-14 - Not Graded ECI-15 - Not Graded c. 2023 Hematology / Coagulation 2nd Event Analyte / Method: Basophil (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Eosinophil (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Lymphocyte (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Monocyte (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Neutrophil, seg or band (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: NRBC/100 WBC (DIF) (%)^ Sample - Performance DIF-02 - Not Graded Analyte / Method: Platelet estimate (DIF)^ Sample - Performance DIF-01 - Not Graded Analyte / Method: Blood Cell ID (Educational) Sample - Performance ECI-06 - Not Graded ECI-07 - Not Graded ECI-08 - Not Graded ECI-09 - Not Graded ECI-10 - Not Graded The surveyor requested laboratory documentation of performance review for the above analytes/methods not evaluated or scored by the PT program, and none were provided. 2. In an interview on 01/11/2024 at 01:45 p.m., in the laboratory, TP-1 confirmed the laboratory failed to evaluate and document proficiency testing performances in Hematology and Coagulation that were not evaluated or scored by a CMS-approved PT program for 3 of 5 events in 2022 and 2023. D5400 ANALYTIC SYSTEMS -- 2 of 17 -- CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory control documents, laboratory policy, and laboratory patient test results laboratory failed to meet the condition of Analytic systems for records reviewed in 2022 and January to October 2023 to include the following: 1. The laboratory failed to follow its individualized quality control plan (IQCP) to perform a positive and negative QC every 30 days for 2 of 2 panels ran on the BioFire Film Array 2 for records reviewed from January 2022 to October 2023. (Refer to D5445) 2. The laboratory failed to have a step-by-step procedure for the establishment and implementation of statistical parameters (mean and standard deviation (S.D.)) for two of two lot roll overs of unassayed control materials put into use on the Architect ci8200 in December 2022 and September 2023. (Refer to D5403) 3. The laboratory failed to ensure expired chemistry reagents were removed from the Abbott Architect ci8200 analyzer before being used in patient testing for 15 patients reviewed for nine of nine instances identified in records reviewed in May 2022 and June 2023. (Refer to D5417 I) 4. The laboratory failed to document acceptable QC prior to reporting patient results for 19 of 19 patients reviewed in June 2023. (Refer to D5481) D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policy, the Centers for Medicare and Medicaide Services (CMS) form 116, patient results and confirmed in interview, the laboratory failed to follow its policy for the centrifugation of urine for urine sediment analysis for 22 of 22 months reviewed from January 2022 to October of 2023. The findings included: 1. In a tour of the laboratory on 1/11/2024 at 0925 hours, surveyor noted a "LabCorp horizon mini E" centrifuge next to the Cobas u411 urine analyzer. Surveyor queried for the centrifuge used for urine sediment analysis and testing person (TP) 1 indicated the LabCorp horizon mini E centrifuge was utilized. 2. Review of laboratory policy titled "Microscopic Examination of Urine" , section "Procedure" had the following instructions: "All urine specimens will receive a microscopic inspection. After running the macroscopic chemistry, centrifuge the disposable centrifuge tube for 2 minutes @ 2000 RPM ..." 3. Review of the laboratory form titled "Centrifuge Maintenance Log" for had the following centrifuge verification performed: Centrifuge - Measured RPM - ... - ... - Date Centrifuge Checked "Horizon - 3373RPM - 4/20/2023" 4. Review of the CMS116, section VIII "Non-Waived testing" listed an annual test volume of 6,661 for urinalysis to include -- 3 of 17 -- the following random 20 patients with urine microscopic testing performed: Patient MRN - Date Tested CUEJUA0001 - 11/22/2022 HELSAR0001 - 11/22/2022 STETHO0004 - 11/22/2022 PATROY0001 - 11/22/2022 DECCRA0001 - 11/22/2022 ROGMAR0002 - 11/22/2022 CALDON0001 - 11/22/2022 THOMAR0006 - 11/22 /2022 HOWDEB0001 - 11/22/2022 GARDON0001 - 11/22/2022 DAVALE0002 - 3 /06/2023 KOKPAU0001 - 3/06/2023 HARULY0001 - 3/06/2023 BILCAR0001 - 3/09 /2023 SINJAM0004 - 3/13/2023 SHEDOR0001 - 3/20/2023 BACFLO0001 - 3/27 /2023 SHUSLO0001 - 3/27/2023 DICCHA0001 - 3/27/2023 ZZZZZZ0019 - 4/28 /2023 5. In an interview on 1/11/2024 at 15:46 hours, in the laboratory, testing person (TP) 1 confirmed that all patients with a urinalysis received a urine microscopic, and that the RPM on the horizon mini E centrifuge used to spin down urine for urine sediment analysis was too fast. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)