Diagnostic Clinic Of Longview

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on November 3, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 45 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records, the laboratory failed to achieve successful performance in two of two 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 -- consecutive testing events for 2025, resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) testing records for 2025, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 2 of 2 consecutive testing events for the chemistry analyte Aspartate Aminotransferase (AST). Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the chemistry analyte AST: Analyte - Event - Score AST, 2025 Event 2 - 60% AST, 2025 Event 3 - 0% 2. A desk review of the API proficiency testing records for 2025 confirmed that the laboratory received a score of 60% for AST during event 2 and 0% for AST in event 3. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the chemistry analyte Aspartate Aminotransferase (AST) for two of two events in 2025. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the chemistry analyte Aspartate Aminotransferase (AST) for two of two consecutive events in 2025. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of laboratory policy, surveyor observation, patient test records, and confirmed in interview, the laboratory failed to handle patients according to laboratory policy for six of six patients submitted for complete blood counts (CBC's) testing on the Sysmex XN-2000 hematology analyzer. The findings include: 1. Review of the laboratory policy titled "XN-2000 Hematology Analyzer", section II "Specimen requirements, subsection F had the following statement: "Do not place CBC and Diff samples on a mechanical rocker. Constant rocking may alter white cell membranes, resulting in false interpretive messages." 2. Surveyor observation on 2/16/2022 at 0943 hours had the following six patients for CBC testing placed on a mechanical rocker next to the XN-2000 Hematology analyzer: 3201419 3201467 3201491 3200532 3200565 3201490 3. In an interview on 2/16/2023 at 09:43 hours, in the laboratory, testing person (TP) 2 confirmed that it was the laboratory practice to place CBC on the mechanical rocker before testing on the XN-2000 Hematology Analyzer. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- -- (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 review of the manufacturer's calibrator instructions for use, reagent test lists for the two Architect Chemistry Analyzers, and interview of facility personnel, the laboratory failed to perform calibration verification procedures for 17 analytes tested on both Architect Chemistry analyzer at least every 6 months in 2022. The findings included: 1. Based on review of the manufacturer's package inserts for calibrators found: a. The Multiconstituent Calibrator ( 2 calibrators -Cal 1 and Cal 2) is intended for use in the calibration of the Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactic Acid, Magnesium, Phosphorous, Total Protein, Triglyceride, Urea Nitrogen, and Uric Acid assays. b. The ICT Serum Calibrator ( 2 calibrators Cal L and Cal H) is intended for use in calibration of the Sodium, Potassium, and Chloride assays. 2. Review of the reagent test lists for the two Architects (SN 36220 and SN 36120) found the 17 analytes calibrated with two calibrators were routinely tested on both analyzers. 3. Interview of testing person 4 on the CMS Report 209 Laboratory Personnel Report conducted February 15, 2023 at 12:22 PM in the laboratory confirmed she had not performed calibration verification procedures at least once every 6 months for analytes calibrated with less than 3 calibrators. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy and confirmed in interview, the laboratory failed to have a policy in place for the Sysmex XN-2000 Hematology analyzer that specified -- 2 of 5 -- the number, type, and frequency of control materials used in determining acceptability for patient testing since the analyzer was implemented for use in October 2022. The findings include: 1. Review of the laboratory policy titled "XN-2000 Hematology Analyzer", approved by the laboratory director (LD) on 11/7/2022, section "V. Quality Control", subsection "C. Frequency of Control use and review" had the following statement and incomplete template: "Complete this section with your laboratory's policy for commercial control analysis and review frequency." "XN CHECK control levels: ______ will be run on 1st shift. XN CHECK Control levels: ______ will be run on 2nd shift. XN CHECK Control levels: ______ will be run on 3nd shift. The supervisor reviews commercial and X-barM charts every ________. The supervisor reviews the QC reports at the following intervals: - Insight IQAP every _______." Surveyor queried if a completed policy had been in place for testing personnel and none was provided. 2. In an interview on 2/15/2023 at 14:15 hours, in the conference room, the technical supervisor (TS) 1 confirmed that the laboratory policy for the Sysmex XN-2000 Hematology analyzer was missing the number, type, and frequency of quality control used in determining acceptability. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory documents, surveyor observation, laboratory quality control records, patient test results, and confirmed in interview, the laboratory failed to ensure that QC was acceptable before reporting patient test results for one of one patients tested with the Vitek 2 ANC cards, used in the identification of anaerobic bacteria, in a record reviewed from 2022 and 2023. The findings include: 1. Review of the laboratory document titled "Quality Control Frequency Cheat Sheet" listed the QC frequency for the Vitek 2 ANC identification cards as every new lot or shipment. Surveyor queried for the laboratory protocol when Vitek QC failed to meet the expected results, testing person (TP) 2 stated they will rerun the QC for the organisms that failed to achieve the expected results. 2. In a tour of the microbiology department on 2/16/2023 at 14:30 hours, the surveyor noted one box of Vitek 2 ANC cards, lot number 2242019503, had a received date of 2/8/2022. A review of QC documents for the Vitek ANC identification, lot number 2242019503, card had the following unacceptable QC performed on 2/16/2022: Organism: Clostridium perfringens 13124 Biochemical: Actual, Expected dMAL: - , + MTE: -, + SAC: -, + Organism: Clostridium septicum 12464 Biochemical: Actual, Expected OPS: -, + Surveyor queried for documentation that the above organisms were rerun to ensure that the Vitek ANC Identification card met the expected results, and no documentation was provided. 3. Review of patient results had the following patient-reported tested with the Vitek 2 ANC identification card when the quality control for the Vitek 2 ANC did not meet expected results: Patient ID: 518430, resulted on 2/6/2023 4. In an interview on 2/16/2023 at 1430, in microbiology, TP2 confirmed that the QC for the Vitek 2 ANC identification card had not been within the laboratory's acceptable limits before testing patients. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) -- 3 of 5 -- (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5619 CYTOLOGY CFR(s): 493.1274(b)(3) (b) Staining. The laboratory must have available and follow written policies and procedures for each of the following, if applicable: (b)(3) Nongynecologic specimens that have a high potential for cross-contamination must be stained separately from other nongynecologic specimens, and the stains must be filtered or changed following staining. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures for identifying nongynecologic specimens with a high potential for cross-contamination and staining them separately from other nongynecologic specimens and filtering or changing the stains following staining. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for identifying nongynecologic specimens with a high potential for cross-contamination and staining them separately from other nongynecologic specimens and filtering or changing the stains following staining. 2. During an interview with the Survey Team on May 19, 2021 at 9:00 AM the Cytology Supervisor confirmed these findings. D5641 CYTOLOGY CFR(s): 493.1274(d)(2)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(2)(ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. The formula-- Number of hours examining slides X 100 / 8 is used to 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 -- determine maximum slide volume to be examined; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory documents and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that the workload limits for two of two Technical Supervisors would be prorated when examining slides in less than eight hours. The laboratory failed to document prorated workload limits for two of two Technical Supervisors when examining slides in les than an eight-hour day in 2020 and 2021 to the date of the survey. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to prorate the workload limits for two of two Technical Supervisors when examining slides in less than an eight-hour day. 2. The Survey Team requested and the laboratory failed to provide documentation of prorated workload limits for two of two Technical Supervisors when examining slides at the laboratory in less than eight hours. Technical Supervisors include: - Technical Supervisor #1 - Technical Supervisor #2 3. During an interview with the Survey Team on May 19, 2021 at 9:00 AM the Cytology Supervisor confirmed these findings. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --