Longstreet Clinic

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on July 30, 2026. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Hematocrit (HCT) in 2025 event 2 and 2026 event 1, resulting in an initial unsuccessful participation for Hct. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two of three testing events ( 2nd event of 2025 and 1st event of 2026), resulting in an initial unsuccessful participation for HCT. Findings: 1. A review of Casper Report 155 revealed the laboratory failed HCT on the following: 2025 Event 2 HCT Score 40% 2026 Event 1 HCT Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed HCT with the aforementioned scores. 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 the CMS CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 review of the CMS CASPER Report 155 and the American Proficiency Institute (API) 2025 event 2 and 2026 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Hematocrit (HCT) in two out of three testing events (2025 event 2 and 2026 event 1), resulting in the initial unsuccessful participation for HCT. -- 2 of 2 --

Summary Statement of Deficiencies D0000 On January 03, 2024 an off site follow-up review was completed. The report revealed that the

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 06, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A review of laboratory personnel records and an interview with the laboratory manager, revealed that the laboratory director failed to provide annual Competency Assessment for ALL its testing personnel. Findings include: 1. A review of testing personnel records revealed there was no competency evaluations for testing personnel (TP#s 3,4,5,7 CMS 209) in 2018. 2. An interview with the laboratory manager on August 06, 2019 at 12:36 PM in the review room confirmed that there were no annual competencies performed on testing personnel #s 3,4,5 and 7 on CMS 209. 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 --