Forsyth County Health Department

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 25, 2025. 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) (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: A review of the 2023 - 2024 AAB Proficiency Testing Documents, confirmed that the Laboratory Director (LD) failed to sign and date the attestation documents. THE FINDINGS INCLUDE: 1. A review of the 2023 - 2024 AAB Proficiency Testing documents confirmed that the LD failed to sign the Attestation statements for : 2023 CHEM M2 EVENT; 2023 CHEM M3 EVENT; 2024 CHEM M1 EVENT; 2024 CHEM M2 EVENT; 2024 CHEM M3 EVENT. 2. An exit interview conducted with TP1 on February 27, 2025 in the conference room at 12:30pm confirmed that the LD did not sign the Attestation documents. 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 On March 26, 2023 an off site follow-up review was completed. The report revealed that the

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 15, 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: 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 the review of Proficiency Testing (PT) records and interviews with the nurse manager, the laboratory director failed to review and attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of the Medical Laboratory Evaluation(MLE) PT records revealed the laboratory failed to provide or retain the signed attestation forms for (MLE) PT events #s M2 of 2019 and M1 of 2020 in Forsyth County. 2. An interview with the nurse manager on 03/10/2021 at approximately 12:40 pm in the Forsyth County HD break room confirmed the PT documents were not reviewed and signed by the laboratory director. 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. 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 -- This STANDARD is not met as evidenced by: Based on observation during the tour and an interview with the nurse manager, the laboratory failed to implement and established safety procedure to ensure protection from physical, biochemical, and biohazardous materials. Findings include: 1. During the laboratory tour it was observed there was no eyewash equipment installed or un- expired eyewash bottle or eyewash log in the phlebotomy or laboratory testing area in 2019, 2020. 2. An interview with the nurse manager during the tour on 03/10/2021 at approximately 10:30 a.m., confirmed the absence of eyewash equipment and maintenance log in 2019 and 2020. 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 November 6, 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: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP), peer review documents, and staff interview, the laboratory failed to follow laboratory policy and procedure as required. Findings include: 1. Review of the laboratory SOP and peer review document review revealed three of six counties (White, Dawson, and Towns) failed to perform Potassium Hydroxide (KOH)/wet mount peer reviews every six months in 2017 and 2018, thus far. 2. SOP review and peer review document review revealed three of six counties (Union, Forsyth, and Lumpkin) failed to follow the SOP policy and procedure for nurse practitioners versus registered nurses to perform twice yearly KOH/wet mount peer reviews in 2017 and 2018 thus far. 3. An interview with the County Nurse Manager on 11/6/18 in a conference room at the Town County Health Department at approximately 2:30 p.m. confirmed the aforementioned lack of peer review performance per the laboratory SOP. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 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 temperature log document review and staff interview, the laboratory failed to monitor laboratory temperature as required. Findings include: 1. Temperature document review revealed laboratory temperature was not documented for the following counties: 2017 -- White, Dawson, and Union; 2018 counties (thus far) -- White and Union. 2. An interview with the County Nurse Manager in a conference room at the Towns County Health Department on 11/6/18 at approximately 2:30 p.m. confirmed the aforementioned undocumented temperatures. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on calibration document review and staff interview, the laboratory failed to calibrate laboratory equipment as required. Findings include: 1. Calibration document review revealed laboratory centrifuge calibration records were not available at the time of survey for 2017 and 2018, thus far, for the following counties: White, Dawson, Union, Forsyth, Lumpkin, and Towns. 2. Calibration document review revealed laboratory microscope calibration records were not available at the time of survey for 2017 for the following counties: White, Forsyth, Lumpkin, and Towns. 3. Calibration document review revealed laboratory microscope calibration records were not available at the time of survey for 2018 for the following counties: Lumpkin and Towns. 4. An interview with the County Nurse Manager on 11/6/18 in a conference room at the Towns County Health Department at approximately 2:30 p.m. confirmed the aforementioned undocumented centrifuge and microscope calibrations for 2017 and 2018. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual (SOP), TP document review, and staff interview, the laboratory director (LD) failed to provide administrative oversight for the laboratory as required. Findings include: 1. Review of the laboratory SOP and TP document review revealed there were no designee letters for individuals qualified to perform TP competencies for 2017 and 2018, thus far, for the following counties: White, Dawson, and Forsyth. 2. White County TP document review revealed the 2018 six-month competency for Staff #2 was performed by unqualified TP. 3. Forsyth County TP document review revealed the following 2018 annual competencies were performed by unqualified TP: (CMS 209 -- Staff #1, Staff #2, and Staff #3). 4. An interview with the County Nurse Manager (CNM) on 11/6/18 in a conference room at the Towns County Health Department at approximately 2:30 p.m. confirmed there were no designee letters in the SOP for individuals qualified to perform TP competencies for 2017 and 2018 thus far. During the same interview, the CNM confirmed the aforementioned TP competencies were performed by unqualified TP. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) 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. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the laboratory director (LD) failed to ensure TP initial training competencies were performed as required. Findings include: 1. TP document review revealed 2017 initial competencies were not performed in Forsyth County for the following : Staff #1 (CMS 209), Staff #2 (CMS 209), and Staff #3 ( CMS 209). 2. An interview with the County Nurse Manager on 11/6/18 in a conference room at the Towns County Heath Department at approximately 2:30 p.m. confirmed the aforementioned initial competencies were not performed in 2017 at the Forsyth County Health Department laboratory.. 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