Hall County Health Department

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 9, 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: 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 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 proficiency test (PT) record review and staff interview, the laboratory failed to maintain a copy of all PT records as required. Findings include: 1. Medical Laboratory Evaluation (MLE) PT document review revealed the lack of an attestation statement for Habersham County for 2020 MLE-M3 -- KOH(potassium hydroxide) and Wet Prep(Wet Preparation). 2. An interview with Staff #3(CMS 209 form - Page 3) on March 9, 2021 at approximately 2:00 PM in the conference room confirmed the aforementioned lack of attestation statement. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) 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 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency test (PT) record review and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 5, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was 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 proficiency test (PT) document review and staff interview, the laboratory director (LD) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. Medical Laboratory Evaluation PT document review revealed the LD did not sign the attestation statement for the 2018 third event for Potassium Hydroxide (KOH)/Wet Preparation. 2. An interview with the Hall County Public Health Nurse Specialist in a conference room on 2/5/2019 at approximately 4:45 p.m. confirmed the LD did not sign the aforementioned PT attestation statement. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of room temperature (RT) and humidity log review, the laboratory failed to provide required stated performance specifications. Findings include: 1. RT log review for Rabun, Stephens, and Habersham Counties revealed no acceptable RT range on the log sheet. 2. Humidity log review for Stephens and Habersham Counties revealed no acceptable humidity range on the log sheet. 3. An interview with the Hall County PHNS in a conference room on 2/5/2019 at approximately 4:45 p.m. confirmed the aforementioned lack of acceptable ranges. 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 humidity log review and staff interview, the laboratory failed to monitor humidity as required. Findings include: 1. Franklin County humidity document review revealed no humidity logs were available for the following: 2017; 2018 January through December 19th. 2. Hart County humidity document review revealed no humidity logs were available for the following: 2017; 2018 -- January through November. 3. An interview with the Hall County PHNS in a conference room on 2/5 /2019 at approximately 4:45 p.m. confirmed the aforementioned unavailable humidity documentation. 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 room temperature (RT) logs, humidity logs, and testing personnel (TP) competencies, the laboratory director (LD) failed to designate qualified testing personnel (TP) to perform document review due to lack of educational qualifications or laboratory experience. Findings include: 1. Franklin County RT log review revealed unqualified TP performed review for the following months: 2017 -- September and March; 2018 -- February, June, and October. 2. Stephens County -- 2 of 5 -- Humidity log review revealed unqualified TP performed review for December, 2018. 3. Habersham County TP document review revealed the 2018 annual competency for Staff #9 (CMS 209 - Page 2) was performed by unqualified TP due to lack of laboratory experience. 3. An interview with the Hall County PHNS in a conference room on 2/5/2019 at approximately 4:45 p.m. confirmed the aforementioned RT log review, humidity log review, and TP competency performance by unqualified TP. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require