Family Medical Group Of Texarkana, Llp

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)