Family Medical Group Of Texarkana, Llp

Summary Statement of Deficiencies D0000 As result of a recertification survey conducted on 6/16/2026, the laboratory was found out of compliance with the following condition level deficiencies: 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; D5400 ANALYTIC SYSTEMS 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 documentation, laboratory policies and procedures, laboratory control records, and patient testing, the laboratory failed to ensure the overall quality of the analytic system through the monitoring of chemistry calibration verification acceptability every six months from March 2025 through March 2026 (D5439), and failed to ensure the accuracy of the test system through daily quality control acceptability before patient testing occurred on the Chemistry Architect C4100 analyzer (D5481) for records reviewed in January and February 2026. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 review of laboratory calibration documentation and confirmed in interview the laboratory failed to ensure calibration verification was assessed for acceptability on the Chemistry Architect C4100 analyzer, for records reviewed from March 2025 through March 2026. The findings included: 1. Review of laboratory calibration verification documentation included the following 32 analytes that the laboratory performed calibration verification on the Chemistry Architect C4100 system: Free Thyroxine, Testosterone, Thyroid Stimulating Hormone, Thyroxine, Vitamin B12, 25- OH Vitamin D, Albumin, Alkaline Phosphatase, ALT / SGPT, AST / SGOT, Direct Bilirubin, Calcium, Carbon dioxide, Chloride, HDL, Cholesterol, Creatinine, Ferritin, Glucose, Hemoglobin A1c, Iron, Total, Magnesium, Potassium, PSA, Sodium, Total Protein, Triglycerides, UIBC, measured, Urea Nitrogen, Uric Acid, Urine Creatinine, Urine Microalbumin. 2. Review of laboratory calibration verification documentation for 2025 and 2026 included the following analytes where calibration verification was performed, but their had been no assessment for acceptability. 3/26/2025: CO2, Glucose, Total Cholesterol, Total Protein, Potassium, Magnesium, Sodium, Triglycerides, Uric Acid: raw data available, no assessment for acceptability. September 2025 - raw data available, no assessment for acceptability, for all analytes. March 2026 - raw data available, no assessment for acceptability, for all analytes. Surveyor asked for testing person 1 for the assessment of acceptability for the above, and none could be provided. 3. In an interview on 6/16/2026 at 1435, in the office, TP 1 and the technical consultant confirmed the calibration verification for the above had not been assessed for accuracy and acceptability. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers 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 policy, laboratory quality control documentation, patient test list, and interview, the laboratory failed to ensure quality control (QC) was acceptable prior to the resulting of 237 of 237 patient results from the Architect -- 2 of 7 -- C4100 chemistry analyzer for QC records reviewed from January to March 2026. The findings included: 1. Review of the laboratory policy titled "Quality Control Policy", section "Remedial Action", included the following information: "A. When an analysis is found to be out of control (outside +/- 2SD), a Systematic effort must be made to resolve the problem. ... 5. If the value is still out, rerun with a new reagent or kit, and or recalibrate if necessary. Contact technical services if necessary. Do not report patients until the outliers are within acceptable limits. " 2. Review of quality control records included the following analytes and days where QC was out of laboratory acceptability for two or more levels of QC and patients had testing performed: Total Protein QC Level 1, Lot 14407241, exp 6/30/27 Mean 4.3403 g/dL SD 0.10485 g/dL QC Acceptability [4.3403 - 4.7597g/dL] 01/12/2026 11:26 - 5.1 g/dl 14:34 - 5 g/dL 16: 32 - 5 g/dL QC Level 2, lot ctrl 14407242, exp 6/30/2027 Mean 5.67846 g/dL SD 6.14 g/dL QC Acceptability [5.67846 - 6.60154 g/dL] 1/12/2026 11:36 - 6.9 g/dL 14: 34 - 6.9 g/dL 16:32 - 6.9 g/dL On 1/12/2026 the following 51 patients had total protein testing performed when 2 or more levels of quality control failed laboratory acceptability: 306917, 306937, 307041, 306908, 306892, 307066, 306940, 306997, 307030, 306925, 306907, 306982, 306995, 306936, 306971, 306906, 306963, 307021, 307051, 306884, 307026, 306974, 307009, 307095, 307097, 307013, 307077, 306960, 307003, 307114, 306894, 307047, 306970, 307058, 306881, 307090, 307101, 307083, 306896, 306914, 306929, 306945, 306955,306955, 306973, 307007, 307061, 307069, 307070, 307128, 307129 Urea QC Level 1, Lot 14407241, exp 6.30.2026 Mean 8.89 mg/dL SD 0.42728 mg/dL QC Acceptability [8.03544 - 9.74456 mg/dL] Date 01/13/2026 11:21 - 12 mg/dL QC Level 2, lot 14407242, exp 6 /30/3037 Mean 40.3 mg/dL SD 1.84108 mg/dL QC Acceptability [36.61784 - 43.98216 mg/dL] 01/13/2026 11:26 - 45 mg/dL On 1/13/2026 the following 39 patient has urea testing performed when 2 or more levels of quality control failed laboratory acceptability: 307170, 307168, 307132, 307191, 307249, 307184, 307318, 307146, 07247, 307220, 307314, 307219, 307227, 307163, 307144, 307261, 307295, 307321, 307325, 307214, 307278, 307172, 307244, 307286, 307277, 307238, 307269, 307274, 307272, 307261, 307333, 307181, 307188, 307238, 307269, 307274, 307298, 307302, 307309, FT4 - Free Thyroxine QC Level 1, lot 1003941, exp 8/31/2027 Mean 0.97813 ng/dL SD 0.0358 ng/dL QC Acceptability [0.90653 - 1.04973 ng/dL] 02/03/2026 12:45 - 0.88 ng/dL 15:03 - 0.88 ng/dL 02/05/2026 16:10 - 0.89 ng/dL QC Level 2, lot 1003942, exp 8/31/2027 Mean 2.22778 ng/dL SD 0.163 ng /dL QC Acceptability [1.90178 - 2.55378 ng/dL] 02/03/2026 12:50 - 1.88 ng/dL 15:20 - 1.83 ng/dL QC Level 3, lot 1003943, exp 8/31/2027 Mean 4.38 ng/dL SD 0.246 ng /dL QC Acceptability [3.888 - 4.872 ng/dL] 02/03/2026 12:57 - 3.55 ng/dL 15:14 - 3.71 ng/dL 02/05/2026 16:22 - 3.69 ng/dL On 2/3/2026 the following four patients had FT4 testing performed when 2 or more levels of quality control failed laboratory acceptability: 309906, 309763, 309782, 309912. On 2/5/2026 the following four patients had FT4 testing performed when 2 or more levels of quality control failed laboratory acceptability: 310415, 310304, 310267, 310283 ALT - Alanine transaminase QC Level 1, lot 14407241, exp 6/30/2027 Mean 26.5 U/L SD 1.42147 U /L QC Acceptability [23.65706 - 29.34294 U/L] 02/06/2026 14:31 - 30 U/L 16:04 - 30 U/L QC Level 2, lot 14407243, exp 6/30/2027 Mean 225.78161 U/L SD 7 .997 U/L QC Acceptability [209.78761 - 241.77561 U/L] 02/06/2026 14:40 - 243 U/L 16:05 - 243 U/L On 2/6/2026 the following 43 patients had ALT testing performed when 2 or more levels of QC failed laboratory acceptability: 310474, 310558, 310626, 310643, 310490, 340582, 310592, 310514, 310464, 310547, 310455, 310485, 310501, 310493, 310528, 310489, 310621, 310459, 310539, 310466, 310478, 310509, 310541, 310525, 310444, 310607, 310511, 310530, 310483, 310585, 310521, 310569, 310570, 310470, 310495, 310515, 310534, 310536, 310555, 310556, 310567, 310577, 310651. AST - Aspartate aminotransferase QC Level 1, lot -- 3 of 7 -- 14407241, exp 6/30/2027 Mean 49.15 U/L SD 2.275 U/L QC Acceptability [44.6 - 53.7 U/L] 02/05/2026 11:56 - 55 U/L 12:57 - 54 U/L 02/06/2026 16:04 - 55 U/L 20: 53 - 55 U/L QC Level 2, lot 14407242, exp 6/30/2027 Mean 149.55263 U/L SD 3.96 U/L QC Acceptability [141.63263 - 157.47263 U/L] 02/05/2026 12:00 - 159 U/L 12: 57 - 158 U/L 02/06/2026 14:36 - 159 U/L 16:04 - 161 U/L Level 3, ctrl 14407243, exp 6/30/2027 Mean 334.69136 U/L SD 11.995 U/L QC Acceptability [310.70136 - 358.68136 U/L] 02/05/2026 12:05 - 359 U/L 12:58 - 362 U/L On 2/5/2026 the following 53 patients had AST testing performed when 2 or more levels of quality control failed laboratory acceptability: 310355, 310431, 310307, 310424, 310356, 310276, 310294, 310337, 310381, 310346, 310262, 310327, 310305, 310360, 310310, 310273, 310289, 310258, 310379, 310311, 310239, 310297, 310416, 310339, 310368, 310428, 310296, 310237, 310432, 310435, 310413, 310285, 310246, 310420, 310243, 310266, 310406, 310319, 310240, 310451, 310343, 310282, 310402, 310272, 310300, 310312, 310324, 310332, 310373, 310375, 310382, 310388, 310449 On 2/6/2026 the following 43 patients has AST testing performed when 2 or more levels of quality control failed laboratory acceptability: 310474, 310558, 310626, 310643, 310490, 310582, 310592, 310514, 310464, 310547, 310455, 310485, 310501, 310493, 310528, 310489, 310621, 310459, 310539, 310466, 310478, 310509, 310541, 310525, 310444, 310607, 310511, 310530, 310483, 310585, 310521, 310569, 310570, 310470, 310495, 310515, 310534, 310536, 310555, 310556, 310567, 310577, 310651. 3. In an interview on 6/16 /2026 at 12:30 hours, in a patient exam room, the technical consultant confirmed that patients had testing performed when QC documentation was out of laboratory acceptability. D5781

Summary Statement of Deficiencies D0000 An onsite survey conducted 05/24/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of laboratory verification documentation, laboratory chemistry test menu, and confirmed in interview the laboratory failed to ensure that patient reference ranges were appropriate for the laboratory's patient population with the implementation of the new chemistry analyzer put into use for patient testing starting May 2023. The findings included: 1. Review of the laboratory provided implementation binders for the Abbott Ci4100 chemistry analyzer put into use May 2023 did not include documentation of a reference range verification for chemistry testing performed on the analyzer before it was put into use for patient testing. 2. Review of the laboratory test menu included the following 35 chemistry analytes: Albumin, alkaline phosphatase, ALT, AST, Bilirubin direct, bilirubin total, urea, calcium, total T4, free T4, TSH, Ferritin, PSA, Vitamin D 25-OH, SHBG, creatin, potassium, total protein, sodium, triglycerides, uric acid, UIBC, PSA, Vitamin B-12, chloride, cholesterol, HDL, CO2, Creatinine, glucose, iron, magnesium, A1C, 2Gen testosterone, Microalbumin 3. In an interview on 5/24/2024 at 13:20, in the office, testing personnel (TP) 1 confirmed the laboratory did not verify patient reference 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 -- ranges were appropriate on the new Abbott Ci4100 Chemistry analyzer before it was put into use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on September 21, 2022, 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 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 desk of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory failed to achieve successful 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 -- performance for the chemistry analyte Total Bilirubin in two of three consecutive testing events in 2021 and 2022 resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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, and American Proficiency Institute (API) proficiency testing records from 2021 and 2022, the laboratory failed to achieve a testing event score of satisfactory performance (80% or greater) for two out of three consecutive testing events for the analyte Total Bilirubin. Two out of two, or two out of three consecutive testing events of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A desk review of the CASPER Report 155 listed the following scores for the API PT Program analyte Total Bilirubin in 2021 and 2022: 2021 Event 3 - 40 2022 Event 2 - 40 2. A proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2021 and 2022 confirmed that the laboratory received a score of 40% for the Chemistry Core analyte Total Bilirubin for the 3rd Event of 2021 and the 2nd Event of 2022. 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 and 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 Total Bilirubin. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for the analyte Total Bilirubin for two of three consecutive events in 2021 and 2022. Refer to 2096. -- 3 of 3 --

Summary Statement of Deficiencies 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)