Erlanger Primary Care - Ringgold

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 27, 2025. 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 deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three events (2nd event of 2024 and 1st event of 2025), 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 -- resulting in the first unsuccessful occurrence for Hematology analyte- hematocrit (HCT). Findings include: 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 Report 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three testing events (2nd event of 2024 and 1st event of 2025), resulting in the first unsuccessful occurance for hematocrit (HCT). Findings include: 1. A review of Casper Report 155 disclosed the laboratory failed HCT on the following: 2024 Event 2 HCT Score 0% 2025 Event 1 HCT Score 60% 2. A review of the laboratory's proficiency testing reports from College of American Pathology (CAP) 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: The laboratory director failed to maintain compliance with successful hematocrit (HCT) proficiency testing (PT) for two of three consecutive events, resulting in the 1st unsuccessful performance for HCT. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Report 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd events of 2024 and 1st event 2025), resulting in the first unsuccessful occurrence for hematocrit (HCT). Findings include: 1. Review of Casper Report 155 disclosed the laboratory failed analyte HCT: 2024 event 2 with a score of 0% 2025 event 1 with a score of 60%. 2. Review of the laboratory's proficiency testing reports from College of American Pathologists (CAP) confirmed the laboratory failed HCT with the aforementioned scores. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on January 24, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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)

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 6, 2022. 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) document review and staff review, the laboratory failed to rotate personnel who routinely perform the testing in the laboratory. The Findings include: 1. College of American Pathologist (CAP) PT document review revealed that 1 testing personnel out of 2 testing personnel, performed 6 total Events for 2020 and 2021 (2020 and 2021: CAP Event 1, CAP Event 2, and CAP Event 3). 2. During an interview with Testing Personnel (TP) #2 (CMS 209) on April 6, 2022 at 12:15 PM, confirmed that the laboratory failed to rotate personnel for the PT in 2020 and 2021. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and 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 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the general laboratory standard operating procedure manual (SOP) and staff interview, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing. The findings include: 1. The general laboratory procedure manual did not include a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, or how to obtain additional assistance) for staff to follow when sending specimens to reference laboratories (Quest, and LabCorp). 2. During an interview, on April 6, 2022, at 1:00 PM, in the breakroom, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to a reference laboratories. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on March 3, 2020. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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)