Family Medicine Assoc Of Blytheville

Summary Statement of Deficiencies 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 review of the 2024 and 2025 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to have initial successful participation in proficiency testing for the analyte Thyroid- stimulating Hormone (TSH) and the subspecialty of Endocrinology. 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 as cited at D2107, and D2108. D2107 ENDOCRINOLOGY 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 -- CFR(s): 493.843(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 review of the 2024 and 2025 CMS Casper Reports 096D, 0153D and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte TSH. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte TSH in the third proficiency testing event of 2024. B. A review of the proficiency testing results revealed the laboratory received a score of 20% for the analyte TSH in the first proficiency testing event of 2025. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 review of the 2024 and 2025 CMS Casper Reports 096D, 0153D and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the subspecialty of Endocrinology. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% for the subspecialty of endocrinology in the third proficiency testing event of 2024. B. A review of the proficiency testing results revealed the laboratory received a score of 20% for the subspecialty of endocrinology in the first proficiency testing event of 2025. 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 review of 2024 and 2025 proficiency testing results, the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the 2024 proficiency testing events, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the analyte TSH, and the overall subspecialty of Endocrinology. Refer to D2107, and D2108. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the 2022 and 2023 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analytes Albumin, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Total Calcium, Chloride, High Density Lipoprotein, Total Cholesterol, Creatinine, Glucose, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid 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 as cited at D2096. 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 -- 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 review of the 2022 and 2023 CMS Casper Reports 0155D and 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analytes Albumin, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Total Calcium, Chloride, High Density Lipoprotein, Total Cholesterol, Creatinine, Glucose, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Albumin. B. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Alanine Aminotransferase. C. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Amylase. D. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Aspartate Aminotransferase. E. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Total Calcium. F. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Chloride. G. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte High Density Lipoprotein. H. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Total Cholesterol. I. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Creatinine. J. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Glucose. K. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Magnesium. L. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Potassium. M. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Sodium. N. A review of the proficiency testing -- 2 of 3 -- results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Total Protein. O. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Triglycerides. P. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Urea Nitrogen. Q. A review of the proficiency testing results revealed the laboratory received a score of 60% in the second proficiency testing event of 2022 and a score of 0% in the first proficiency testing event of 2023 for the analyte Uric Acid. 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 review of 2022 and 2023 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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: Based on review of the 2022 and 2023 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry tests of Albumin, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Total Calcium, Chloride, High Density Lipoprotein, Total Cholesterol, Creatinine, Glucose, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid. -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: . Through a review of package instruction for Roche Coaguchek, laboratory patient logs, patient medical records, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to follow manufacturer's instructions when performing the Coaguchek test system for evaluating Prothrombin Test (PT) and International Normalized Ratio (INR). Survey Findings Follow: A. A review of Roche Coaguchek package insert revealed the purpose of the test system "The purpose of Coaguchek test system is intended for use by professional healthcare providers for quantitative Prothrombin Time (PT) Testing for monitoring Warfarin therapy." B. A review of Coaguchek patient logs from November 2021- March 2022 August 2019 (5 of 5 months) revealed patient #128297,patient #134549, patient #136025, patient #127262, patient #125638, patient #116424, patient #127535, patient #137810, patient #124531 and patient #131985 (10 of 15 patients reviewed) had PT/INR test performed on Roche Coaguchek. C. A review of medical records for the patients listed above revealed these patients had the PT/INR test performed on the Roche Coaguchek but were not on Warfarin Therapy. D. In an interview on 7/20/2022 at 1500, laboratory personnel #2 (as listed on form CMS-209) confirmed the PT/INR was performed on the patients mentioned above and they were not on Warfarin Therapy. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures 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 -- 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: . Through a review of the laboratory's policy and procedure manual, quality control (QC) data for 2022, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to have a policy for shifts and trends to monitor the accuracy and precision of the quality control process. Survey Findings Follow: A. A review of the policy and procedure manual revealed the laboratory failed to have a policy to monitor shifts and trends for the evaluation of accuracy and precision over time to meet established quality control criteria. B. A review of Levy Jennings charts for April (one of three months reviewed) 2022 revealed: Performance Verifier (PV) Level 1 Control Lot #Y8558, Blood Urea Nitrogen (BUN) results were below the assayed mean of (20.2): Glucose results were below the assayed mean of (87.5) and Creatinine results were below the assayed mean of (1.04). C. A review of Levy Jennings Charts for March 2022 revealed: PV Level 2 Lot #F9070, Potassium results were below the assayed mean of 5.49. Creatinine, Total Bilirubin and Phosphorus results were all below the assayed mean. D. The surveyor requested a policy or procedure to monitor shifts and trends. None was provided. E. In an interview on 7/20 /2022 at 14:30 PM Laboratory testing personnel #2 (as listed on form CMS 209) confirmed the laboratory failed to have a written procedure to monitor shifts or trends. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the Patient and Control Log for Rheumatoid Arthritis (RA) for December 2018 through January 2020, lack of documentation, and interviews with staff, it was determined the laboratory failed to document quality control results when patients were reported for RA. Survey findings include: A. Through a review of the December 2018 through January 2010 Patient and Control Log for RA it was determined that eight out of thirty-one patients who had RA tests performed were reported on days with no quality control documented including a titered result reported on one patient who was reported as positive without a titered control being documented. Patients reported without quality control documentation were #96393 on 11/22/2019, #96833 on 12/4/2019, #57401 (no date), #98042 on 12/27/19, #98521 on 1/9/2020, #98606 on 1/10/2020, #98676 on 1/13/2020, and #98660 on 1/13/2020. Patient #57401 had a titered result reported. B. In an interview at 11:07 on 1/16/2020 the technical consultant (as listed on the form CMS-209) confirmed the lack of documented quality control for the patients listed above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --