Morrilton Medical Clinic, P A

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 analyte Total Bilirubin. 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. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 analyte Total Bilirubin (TBIL) Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a sore of 40% for the analyte TBIL in the second proficiency testing event of 2022. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte TBIL in the first proficiency testing event of 2023. 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 test of TBIL. -- 2 of 2 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of laboratory policies and procedures, a review of quality control documentation, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document establishment of acceptability ranges for quality control. Survey findings include: A. During a review of the policy and procedure manual it was determined the quality control policy is based on ranges set using two and three standard deviations. B. A review of quality control documentation revealed that ranges in use for both hematology and chemistry quality control were wider than calculated standard deviations for the analytes for five of eight chemistry tests reviewed and for all three constituents of the white blood cell differential. C. In an interview, at 11:24 on 10/21/2021, the technical consultant (listed as #5 on the form CMS-209) stated there was no documentation of establishing the standard deviations for hematology. In an interview at 11:49 on 10/21/2021, the technical consultant stated that the chemistry ranges changed with a software upgrade on 2/11 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 -- /2021 and that there was no documentation of establishing the ranges in use since the upgrade. -- 2 of 2 --