District 4 Public Health

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 28, 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: D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Fayette County temperature/humidity logs of May, October, and November 2022 and Eyewash station monthly maintenance log for the year of 2022, review of the letter if delegation, and interview with the Women's Health/STD Coordinator, the lab director (LD) failed to ensure the delegated Technical Consultant (TC) performed all assigned duties properly. Findings: 1. Review of the Eyewash station monthly maintenance log of January 2022 through December 2022 revealed the form was not reviewed or dated by the delegated TC. 2. Review of the temperature /humidity logs for the months of May 2022, October 2022, and November 2022 revealed the form was not reviewed or dated by the delegated TC. 3. Interview with the Women's Health/STD Coordinator on 2/28/23 in the back office at 1:30, confirmed the findings. 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 Based on a CLIA recertification survey performed on March 10, 2021, this facility was found to not be in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on laboratory maintenance document review and staff interview, the laboratory failed to ensure protection from physical, chemical, and electrical hazards as required. Findings include: 1. Laboratory maintenance document review revealed the lack of eyewash maintenance logs available at the time of survey for 2018 (October through December). 2. An interview with the District 4 Health Coordinator in the conference room on 3/10/2021 at approximately 1:30 p.m. confirmed the lack of aforementioned eyewash logs. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's Proficiency Testing (PT) records and staff interview, the laboratory failed to ensure PT results were reviewed upon receipt from Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- the PT agency. Findings include: 1. Review of 2019 American Academy of Family Physicians (AAFP) PT records reveals the lab failed to ensure the results received for the subspecialty of Mycology & Parasitology Event B had documented review by appropriate staff to evaluate the laboratory's performance in the following counties: Heard and Coweta 2. Review of 2019 American Academy of Family Physicians (AAFP) PT records reveals the lab failed to ensure the results received for the subspecialty of Mycology & Parasitology Event C had documented review by appropriate staff to evaluate the laboratory's performance in the following county: Pike 3. Review of 2020 American Academy of Family Physicians (AAFP) PT records reveals the lab failed to ensure the results received for the subspecialty of Mycology & Parasitology Event B had documented review by appropriate staff to evaluate the laboratory's performance in the following county: Upson 4. Review of 2020 American Academy of Family Physicians (AAFP) PT records reveals the lab failed to ensure the results received for the subspecialty of Mycology & Parasitology Event C had documented review by appropriate staff to evaluate the laboratory's performance in the following counties: Heard and Upson 4. An interview with the District 4 Health Coordinator in the conference room on March 10, 2021, at approximately 1 p.m. confirmed the lack of documented result review for the aforementioned PT events. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 26, 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 proficiency test (PT) records and interview with the program coordinator, the Laboratory Director failed to attest the routine incorporation of the American Proficiency Institute (API) proficiency test samples into the patient workload using the facility's routine methods. The findings include: 1. Seven (7) out of 13 laboratories in District 4 had no records of signed attestation statements from the Laboratory Director and testing personnel for 2017 and 2018 proficiency test for Vaginal Wet Preparation and Potassium Hydroxide (KOH) Preparation. 2. An interview with the program coordinator on September 26, 2018 at approximately 7 PM in the conference room #109, confirmed these findings. **Repeat Deficiency** D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record 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 6 -- testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and interview with the program coordinator, the laboratory failed to retain copies of all PT events of the American Proficiency Institute (API) proficiency test samples. Findings include: 1. Review of PT records revealed two (2) counties of District 4 did not retain copies of the 2017 test event #2. 2. Review of PT records revealed thirteen (13) of the thirteen (13) counties failed to retain PT laboratory log sheets for 2017 and 2018 thus far. 2. An interview with the program coordinator on September 26, 2018 at approximately 7 PM in the conference room #109 confirmed these findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and interview with the program coordinator, 13 out of 13 laboratories in District 4 failed to review and evaluate the results of the American Proficiency Institute (API) proficiency test for 2017 and 2018 to date. Finding include: 1. There was no evidence that the API proficiency test was reviewed and evaluated by the Laboratory Director for 13 of 13 laboratories in District 4 for 2017 and 2018 to date. 2. Interview with the program coordinator on September 26 at approximately 7 PM in the conference room # 109, confirmed these findings. **Repeat Deficiency** D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory records, procedure manual (SOP), and staff interview, the laboratory failed to establish and verify an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the lab. Findings include: 1. Review of the SOP revealed the lack of a written Quality Assessment (QA) program for thirteen(13) of thirteen (13) counties in District 4. 2. Review of the laboratory's records revealed no documentation of pre-analytic, analytic, or post- -- 2 of 6 -- analytic monitors for twelve (12) of thirteen (13) counties in District 4. 3. Interview with the program coordinator on September 26, 2018 in the conference room #109 at approximately 7 PM, confirmed the missing aforementioned QA. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of