Lowndes County Health Department

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 18, 2025. The facility was found to not be in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 Proficiency Testing (PT) documents from American Association of Bioanalysts(AAB), Medical Laboratory Evaluation (MLE) PT providers, and staff interview, for the years 2023-2024, the laboratory failed to provide a signed attestation statement confirming that the PT specimens were handled in the same manner as patient testing samples. Findings: 1. A review of PT documents, for 2024 (events 1, 2, and 3) confirmed that there were no Attestation Statements available for review for the Specialty of Microscopy. 2. A review of PT documents for 2023 (events 1,2, and 3) confirmed there were Attestation Statements available for review which revealed that approximately 9 nursing supervisors signed the attestation statements as performing the testing of the samples, at their monthly meetings, outside of the normal patient testing processes. 3. Interview with the Laboratory Director, County Nurse Manager, and Nurse Manager of the Lowndes County facility, on 02/18/2025, at approximately 4 pm, in the conference room, confirmed the above aforementioned statements. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 -- (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 Proficiency Testing (PT) documents from American Association of Bioanalysts(AAB), Medical Laboratory Evaluation (MLE) PT providers, and staff interview, for the years, 2023 and 2024, the Laboratory Director (LD) failed to ensure that the signed attestation statements confirmed that PT specimens were handled in the same manner as patient testing samples. Findings: 1. A review of PT documents for 2024 (events 1, 2, and 3) confirmed that the LD did not ensure that attestation statements were available for review in the Specialty of Microscopy. 2. A review of PT documents for 2023 (events 1,2, and 3) confirmed that there were attestation statements available for review with approximately 9 nursing supervisor signatures as performing the testing of the samples, at their monthly meetings, outside ofthe normal testing procedures. 3. Interview with the Laboratory Director, County Nurse Manager, and Nurse Manager of the Lowndes County facility, on 02/18/2025, at approximately 4 pm, in the conference room, confirmed that the Laboratory Director did not ensure the appropriate completion of Attestation Statements. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 14, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the Temperature and Humidity logs, for 2021 and 2022, for all 14 county facilities, in the 8-1 District Health Department (Lowndes County), and confirmed by staff interview, 1 facility did not document the Humidity for 2021 or 2022. Findings: 1. Review of the Temperature and Humidity Logs, for all 14 counties in the Lowndes County Health Department,the Turner County Health Department facility did not record Humidity for 2021, 2022, and up to February 23, 2023. 2. Interview with the District 8-1 Nursing Clinical Director and the Turner County Nurse Manager on February 23, 2023, in the Berrien County Health Department Conference Room , at approximately 4pm, confirmed the above aforementioned statement. D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) The laboratory director is responsible for the overall operation and administration of 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 -- 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)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on review of the Temperature and Humidity Logs, for the 14 county facilities that make up the District 8-1 Georgia Health Departments, and confirmed with staff interview, the Laboratory Director (LD) failed to ensure that the environmental conditions for 1 out of the 14 facilities, in the District 8-1 Georgia Health Department, was monitoring Humidity for 2021, 2022, and 2023 up to February 23. Findings: 1. Review of the Temperature and Humidity Logs for 2021, 2022, and up to February 23, 2023, for the 14 counties making up the District 8-1 Georgia Public Health Departments, 1 county (Taylor County) had not recorded the Humidity for 2021, 2022, and up to February 2023. 2. Interview with the 8-1 District Nursing Clinical Director and the Turner County Nurse Manager, on February 23, at approximately 4pm, in the conference room , in the Berrien County (Nashville Ga) Georgia Public Health conference room confirmed the above aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 23, 2022. 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 three of three consecutive events (1st, 2nd, 3rd event of 2021), 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 -- resulting in the first unsuccessful occurrence for Bacteriology #005. Findings include: Refer to D 2028 D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 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 from the American Association of Bioanalytst (AAB), the laboratory failed to maintain satisfactory performance in three consecutive events (1st,2nd, and 3rd events of 2021), resulting in the first unsuccessful occurrence for Bacteriology #005. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Bacteriology #005 , on events 1, 2, & 3 of 2021 with a score of 60% . 2. Desk review of the laboratory's proficiency testing reports from AAB confirms the laboratory failed Bacteriology #005, resulting in the first unsuccessful performance. 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 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 director failed to ensure the laboratory maintained satisfactory performance in three of three consecutive events (1st, 2nd, and 3rd events of 2021), resulting in the first unsuccessful occurrence for Bacteriology #005. Findings include: Refer to D 6016 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's -- 2 of 3 -- proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in three of three consecutive events (1st, 2nd, and 3rd events of 2021), resulting in the first unsuccessful occurrence for Bacteriology #005. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Bacteriology #005 on events 1,2, & 3 of 2021 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyts (AAB) confirmed the laboratory failed Bacteriology #005 on Events 1, 2, and 3 of 2018, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 06, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following Condition level deficiency was cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the American Associates of Bioanalysts (AAB) Proficiency Testing (PT) documents and staff interview, the laboratory failed to enroll in a CMS- approved proficiency test program for Gynecology (GYN) KOH prep testing. Findings: 1. Based on review of the AAB PT documents the laboratory was not enrolled in a PT program for GYN KOH Prep for the first, second and third events for 2017 and 2018. 2. The Assistant Nurse Manager confirmed on 12/27/2018 at 11:30 am, via phone interview in her office, that the laboratory was not enrolled in a PT Program for GYN KOH for the first, second and third events of 2017 and of 2018. 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 --