Whitfield County Health Department

Summary Statement of Deficiencies D0000 A recertification survey was performed on August 24, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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 quality assessment (QA) monthly reports and interview with the director of nursing (DON), the Whitfield County Adult Health laboratory failed to follow the actions of the QA monthly report. Findings include: 1. Review of the QA report for October 2021 revealed the report was incomplete. The Quality Control (QC) section of the form was blank. 2. Review of the QA report for July 2022 revealed the QC section was marked inappropriately as "Y (yes)". The action was marked that "all required temperatures were taken and recorded appropriately", review of the Lab Temperature/Humidity Log for July 2022 revealed the humidity was out of range (40 - 50 %) 19 of 21 days; therefore, the appropriate response to the action would be "N (no)" and

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 11, 2021. 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: 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 laboratory records review and Nursing director's interview, the laboratory failed to record enviromental conditions appropriately as required by Clinical Laboratory Improvement Amendment guidelines in Whitfield County Lab from 2019 to 2021. Findings include: 1. Temperature records review revealed room temperatures, humidity and refrigerator temperatures were out of range in 2019, 2020 and 2021 in Whitfield County Lab mainly because the Normal Ranges on top of the laboratory maintenance logs were in-correct. 2. An interview the County Nursing director on 08/11/ 2021 at approximately 12:30 PM in the review room confirmed temperatures and Humidity were out range in 2019, 2020 and 2021 due to Normal Range error on maintenance logs. 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 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 14, 2019. 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 quality assurance (QA) document review and staff interview, the laboratory director (LD) failed to ensure the duties of the technical consultant (TC) were properly performed as required. Findings include: 1. Murray County QA document review revealed the TC did not review and sign the monthly QA checklist for the following months: 2017 - July through November; 2018 - April through December; 2019 - January and February. 2. An interview with the District Nurse Manager on March 14, 2019, in a conference room at approximately 2:45 p.m. confirmed the Murray County TC did not review and sign the monthly QA checklist for the aforementioned months. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES 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): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on quality assurance (QA) document review and staff interview, the technical consultant (TC) failed to provide technical and scientific oversight of the laboratory as required. Findings include: 1. Murray County QA document review revealed the TC did not review and sign the monthly QA checklist for the following months: 2017 - July through November; 2018 - April through December; 2019 - January and February. 2. An interview with the District Nurse Manager on March 14, 2019, in a conference room at approximately 2:45 p.m. confirmed the Murray County TC did not review and sign the monthly QA checklist for the aforementioned months -- 2 of 2 --