East Texas Clinic Association

Summary Statement of Deficiencies D0000 An onsite survey conducted 08/25/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 surveyor observation, review of manufacturer instructions, laboratory policy, the Centers For Medicaid and Medicare (CMS) form 116, and confirmed in an interview, the laboratory failed to have a function check protocol in place to ensure equipment performance for accurate and reliable test results for the LW Scientific E8 Portafuge centrifuge used in the preparation of urine sediment for microscopic examination in 2022. The findings included: 1. In a tour of the laboratory on 8/25 /2023 at 10:10 hours surveyor noted the following bench-top centrifuge used to centrifuge urine for urine sediment examination: LW Scientific E8 2. Review of the "USA E8 Portafuge Instruction Manual", section "Specifications" had the following information: "Dial Setting: RPM Range: Low (7:00 position) 500 (+10% - 5%) Medium (12:00 position) 1700 - 1950 Medium (3:00 position) 3150 - 3350 High (5:00 position) 3500 (+10% - 5%)" 3. Review of the laboratory policy manual for urinalysis, section "Microscopic" had the following instructions: "1. Centrifuge the urine specimen at 1750 - 1900 RPM for 2 minutes." The surveyor queried for the 2022 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 -- tachometer checks for the verification of the centrifuge speed to ensure that the was accurate and none was provided. 4. A review of the CMS 116 section VIII "Non Waived Testing", lists the annual test volume for urine sediment examination at 178 tests. 5. In an interview in the laboratory on 8/25/2023 at 10:15 hours TP5 confirmed that the laboratory did not have a mechanism in place to verify the centrifuge speed to ensure accurate and reliable test results for urine sediment microscopic examination. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of laboratory documents, laboratory competency assessments, and confirmed in interview, the technical consultant (TC) failed to perform annual competency assessments for three of five testing personnel (TP) in 2022. The findings included: 1. A review of the laboratory document titled "Personnel Assessment" had the following statement in the first paragraph: "Personnel competency must be assessed by the Laboratory Director or Technical Consultant and will be an on-going process at this facility." 2. A review of the competency assessment forms for 2022 had the following personnel competency assessments performed by personnel who could not meet the TC qualifications found at 493.1411: 2022: TP4 competency assessment performed by TP5 on 4/11/2022 TP2 competency assessment performed by TP5 on 3 /24/2022 TP3 competency assessment performed by TP5 on 11/21/2022 3. In an interview on 8/25/2023 at 10:45 hours, in the office, TP5 confirmed that the TC had not performed the competency assessments for the above testing personnel in 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy, API agency policy, API proficiency test results from 2020-2021 and confirmed in an interview found the laboratory failed to verify one of six PT events per the API agency policy for accuracy of one of one ungraded analyte: urine sediment in 2020 Hematology/Coagulation-3rd event. The findings were: 1. Review of the laboratory's policy titled Policy for Evaluation of Proficiency Testing Performance, "The laboratory director, along with the testing personnel, will review and evaluate all of the proficiency testing scores when results are received and check the accuracy of all tests, including a zero for a late submission, or a 100% score for an ungraded challenge." 2. Review API Proficiency Testing Performance Evaluation page revealed "Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes." 3. Review of the laboratory's API Hematology/Coagulation proficiency testing records from 2020 to 2021 revealed the laboratory had no documentation of review of the analyte with a grade of "not graded" for one of six PT events: 2020 Hematology/Coagulation-3rd event. 2020 Hematology/Coagulation-3rd event Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Microscopy/Urine Sediment Analyte/Method urine sediment Sample: US-06 Reported Result: Cast (granular) Expected Result: See Data Summary 4. An interview with RN on 4/6/22 at 11:00 am in the office confirmed the above findings. Key: API= American Proficiency Institute PT=Proficiency testing RN=Registered Nurse D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's API proficiency test results from 2020-2021 and confirmed in an interview found the laboratory failed to verify the accuaracy of the ananlyte vaginal wet preparation at least twice annually in 2020. The findings were: 1. Review of the laboratory's API Hematology/Coagulation proficiency testing records from 2020 to 2021 revealed unacceptable performance score of 0% for the analyte Vaginal Wet Preparation in Microscopy/Urine Sediment for two of six PT events in 2020 Hematology/Coagulation-1st event and 2020 Hematology/Coagulation- 3rd event. 2. Further review of the laboratory's API Hematology/Coagulation proficiency testing records for 2020 Hematology/Coagulation-1st event and 2020 Hematology/Coagulation-3rd event revealed unacceptable performance score of 0% for the analyte Vaginal Wet Preparation in Microscopy/Urine Sediment for two of six PT events. The unacceptable performance were: 2020 Hematology/Coagulation-1st event Microscopy/Urine Sediment Vaginal Wet Preparation 0% Sample:VA-01 Reported Result: Clue cells seen Expected Result: No yeast, Trich, or clue cells 2020 Hematology/Coagulation-3rd event Microscopy/Urine Sediment Vaginal Wet Preparation 0% Sample:VA-03 Reported Result: Clue cells seen Expected Result: No yeast, Trich, or clue cells 3. An interview with RN on 4/6/22 at 11:00 am in the office confirmed the above findings. Key: API= American Proficiency Institute PT=Proficiency testing RN=Registered Nurse D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation, the laboratory reagent replacement history logs from 12/6/21 to 3/29/22, and confirmed in an interview found the laboratory failed to document a quality control run after a change in a reagent on one of one Sysmex XN-330 hematology analyzer for two of 10 days reviewed. The findings were: 1. The surveyor's direct observation in the laboratory revealed four reagents were used for the XN-330 hematology analyzer (SN#:11446) Cellpack DCL Sulfolyser Lysercell WDF Fluorocell WDF 2. Review of the reagent replacement history logs from 12/6/21 to 3/29/22 revealed two of 10 days reviewed with no -- 2 of 4 -- documentation of the quality control run after the following reagent change on the Sysmex XN-330 (SN#11446) hematology analyzer. 3/4/22 at 9:02 am Cellpack DCL Lot#Y1031 Exp 5/16/2023 3/29/22 at 10:22 am Cellpack DCL Lot#Y1033 Exp 6/26 /2023 3. Review of the patient test records for the above date revealed the laboratory performed two patient testing after the reagent change above with no documentation of the quality control run. 3/4/22 at 11:21 am Patient ID: 23883 3/29/22 at 12:00 pm Patient ID:29115 4. An interview with RN on 4/6/22 at 11:30 am in the office confirmed the above findings. Key: RN=Registered Nurse D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require