Ware County Health Department

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 12, 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: 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: This condition level citation is not met based on review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) documents, and staff interview the laboratory failed to perform tesing in the same manner as they tested patient specimens for the years 2021 and 2022 for the speciality of microbiology, subspecialties- mycology and bacteriolgy. Only one testing personnel performs the testing on patient samples but more than one testing personnel performed testing on the PT samples. Reference: D2006 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it 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 -- receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) documents and staff interview, the laboratory failed to perform testing in the same manner that they test patient specimens for the years 2021 and 2022 for the speciality of microbiology, subspecialties-mycology and bacteriolgy. Only one testing personnel performs the testing on patient samples but more than one testing personnel performed the testing on the PT samples. Findings: 1. Review of the MLE attestation statements for 2021, event M1, there were seven names on the attestation statement performing testing. In the year 2021, event M2, there were seven names on the attestation statement performing the testing. In the year 2021, event M3, there were 4 names on the attestation statement performing the testing. 2. In the year 2022, event M1, there were eight names on the attestation statement performing the testing. In the year 2022, event M2, there were seven names on the attestation statement performing testing. 3. Interview with the Assistant Clinical Coordinator, Southeast Health District, on July 14, 2022, at approximately 3pm in the conference room, confirmed the above aforementioned statements. 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 Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) documents, and staff interview the Laboratory Director (LD) failed to recognize that the laboratory was not performing testing in the same manner that they test patient specimens for the years 2021, and 2022 for the speciality of microbiology, subspecialties- mycology and bacteriolgy. Only one testing personnel performs the testing on patient samples but more than one testing personnel performed testing on the PT samples. Reference: 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) documents, and staff interview the Laboratory Director (LD) failed to insure that the laboratory was performing tesing in the same manner that they test patient specimens for the years 2021 and 2022 for Speciality Microbiology, subspecialties- mycology, and bacteriology. Only one testing personnel performs the testing on patient samples but more than one testing personnel performed the testing on the PT samples. Findings: 1. Review of the MLE attestation statements for 2021, event M1, there were seven names on the attestation statement performing the PT testing. In the year 2021, event M2, there were seven names on the attestation statement performing the PT testing. In the year 2021, event M3, there were 4 names on the attestation statement performing PT testing. 2. In the year 2022, event M1 there were eight names on the attestation statement performing the PT testing. In the year 2022, event M2, there were seven names on the attestation statement performing the PT testing. 2., Interview with the Assistant Clinical Coordinator, Southeast Health District, on July 14, 2022 at approximately 3pm in the conference room, confirmed the above aforementioned statements. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on January 15, 2020. 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: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the Waived testing Quality Control(QC) Documents and manufacturer's package inserts and staff interview, the laboratory was not performing QC in the testing facilities, on new lots, and new shipments, as required by the manufacturer's package insert, but in a central District Pharmacy. Findings: 1. Review of the Waived testing QC documents, all 19 counties had the same copies of QC logs in their facility documents. It was determined that the testing personnel was not performing the QC, but that the QC was being performed in a Central Pharmacy, by the Pharmacy Staff, and then the Waived test kits was sent out to the testing sites by courier. The environment of the courier vehicle was not being monitored for temperature. 2. Staff interview with the Assistant Clinical Coordinator, on January 15. 2020, at approximately 12 pm, in the conference room, confirmed that the QC on all Waived test kits was being performed at the Central District Pharmacy, by the Pharmacy staff and then sent out to each County Health Departments for patient testing, by courier, and the environment of the courier vehicle was not being monitored for temperature. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 charts for the 19 County Health Department(HD) facilities that make up the Southeast Health District, Ware County Health Department, and staff interview, 17 of the laboratories did not document Humidity levels every day of patient testing. Findings: 1. Review of the temperature and humidity charts for the 19 County HDs, the following findings were noted: Out of the 19 County HDs; Three (3) facilities did not have Humidity documented from July 2018, to the current survey date. (January 15, 2020) 14 facilities did not have Humidity documented from January 2019 to April 2019. Two (2) facilities had documented both Humidity and Temperature from July 2018 to the current survey date. (January 15, 2020). 2. Interview with the Assistant Clinical Coordinator, in the Conference Room, on January 15, 2020, at approximately 4 pm, Confirmed the aforementioned findings. -- 2 of 2 --