Longstreet Clinic Pc, The

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 16, 2025. 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: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the review of American Proficiency Institute (API) proficiency testing (PT) documents and staff interview in the specialty of Hematology, the laboratory failed to verify the accuracy of a non-regulated analyte by successfully passing two(2) (PT) events in 2024. Findings: 1.) Review of 2024 (API) (PT) documents revealed in the specialty of Hematology, the laboratory received a score of 0% for Basophils (Hem - 5D) in 2024 event #2 and another 0% score of the same analytes in 2024 event #3 resulting in "Unsuccessful" notation by PT agency. 2.) An interview with the technical consultant (TC) (TP #3 CMS 209) on 01/16/2025 at approximately 1:05 PM confirmed the above findings. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) 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. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic 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 -- consultation as needed. This STANDARD is not met as evidenced by: Based on (PT) documents review and interview with the laboratory manager, the Laboratory director failed to ensure that ALL Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory in 2024 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. American Proficiency Institute (API), Quality Control (QC) and Levey Jennings charts documents review revealed the lab director/ designee did not fully address the fact that WBCs on the Cell-dyn emerald Hematology analyzer did not hit the (QC) mean often from August to October 2024 resulting to WBCs (PT) failures in the last quater of 2024. 2. An interview with the technical consultant (PT# 3 CMS 209) in the review room on 01/16/2025 at approximately 12:30 PM, confirmed the laboratory director/ designee failed to ensure proper oversight of the laboratory's (QA) activities in the last quater of 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 4, 2024. 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficicency Institute (API) reports, the laboratory 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 -- failed to successfully participate in proficiency testing (PT) in 2 consecutive events for red blood cell (RBC) resulting in the initial unsuccessful participation for RBC. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(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 CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in two consecutive testing events for RBC, resulting in the initial unsuccessful participation for RBC. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed RBC on the following: 2023 Event 1 Score 60% 2023 Event 2 Score 0% 2. A review of the laboratory's API Reports confirmed the laboratory failed RBC 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 the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. 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 CMS CASPER Report 155 and the API 2023 events 1 and 2 PT evaluation reports, the laboratory director failed to ensure successful PT participation in two consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 26, 2023. 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: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure the blood agar plates were not used after their expiration date, 6 out of 6 blood agar plates were expired. The Findings include: 1. Observation during the laboratory tour on January 26, 2023 at approximately 11:00 AM revealed 6 blood agar plate were expired on January 17, 2023, and three expired blood agar plates had specimens plated on them. Observation during the same tour at 11:05 AM on January 26, 2023 revealed that three plates were discarded, but the plates that were plated with specimens on them remained, during the time of the survey. 2. During an interview with Technical Consultant(CMS-209) in the laboratory on January 26, 2023 at approximately 11: 00AM, confirmed there were 6 total blood agar plates that were expired and 3 of the plates had specimens on them, during the laboratory tour. 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 --

Summary Statement of Deficiencies D0000 On March 09, 2021 an off site followup review was completed. The report revealed that

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 09, 2018. 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory's lead technician (PT#1 CMS 209) , the laboratory director failed to attest that PT samples were tested in the same manner as patient specimens by failing to sign attestation forms for Hematology/ coagulation event #1 of 2017. Findings include: 1. Review of the American Proficiency Institute (API) PT records revealed the laboratory director failed to sign the attestation documents for the 2017 testing events #1. 2. An interview with the laboratory's lead technician on 10/9/18 at approximately 12:33 PM in the patient review room, confirmed the attestation was not signed. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance(QA) records and an interview with the laboratory's lead technician, the Technical Consultant (TC) failed to review and sign Monthly Quality Assurance report records for July and September of 2018. Findings include: 1. Review of maintenance and Quality Assurance reports revealed QA logs were not reviewed and signed for the months of July and September of 2018 by (TC). 2. An interview with the laboratory's lead technician (TP#1 CMS 209) on 10 /09/2018 at approximately 12:40 pm in the patient review room confirmed the QA reports were not reviewed and signed by the (TC). D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved