Columbus Health Department

Summary Statement of Deficiencies D0000 A recertification survey was performed on .March 28, 2025. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the Testing Personnel (TP) documents, and staff interview, the laboratory failed to provide a copy of a diploma, from an accredited institution for 5 out of 32 total Testing Personnel listed on the Centers for Medicare and Medicaid Services Laboratory Personnel Reports (209) form. Findings: 1. Review of the 209 forms for each County Health Department in the Columbus Health District the following TP did not have educational documents in their Human Resources (HR) folders,on the day of the survey. Copies were requested on the day of the survey. Columbus Health Department - TP 1 and TP 6 did not have education 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 2 -- Sumter County Health Department - TP 1 did not have education documents Crisp County Health Department - TP 2 and TP 3 did not have education documents 2. Interview with the CLIA Manager for the Columbus Health Department, on 3/28 /2025, in the conference Room of Clay County Health Department, at approximately 2 pm, confirmed the aforementioned statements as well as via email on 04/21/2025 at 9: 11 am. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on review of the Testing Personnel (TP) documents, and staff interview, the Laboratory Director (LD) failed to ensure that prior to testing patients' samples that all personnel had the appropriate education and experience for the type and complexity of the services offered. The LD failed to verify that a copy of a diploma, from an accredited institution for 5 out of 32 total Testing Personnel listed on the Centers for Medicare and Medicaid Services(CMS) Laboratory Personnel Reports (209) forms. Findings: 1. Review of the 209 forms for each County Health Department in the Columbus Health District the following TP did not have educational documents in their Human Resources (HR) folders,on the day of the survey. Copies were requested on the day of the survey. Columbus Health Department - TP 1 and TP 6 did not have education documents Sumter County Health Department - TP 1 did not have education documents Crisp County Health Department - TP 2 and TP 3 did not have education documents 2. Interview with the CLIA Manager for the Columbus Health Department, on 3/28/2025, in the conference Room of Clay County Health Department, at approximately 2 pm, confirmed the aforementioned statements as well as via email on 04/21/2025 at 9:11 am. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 20, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following Condition was 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: Based on review of the American Associates of Bioanalysts (AAB) Proficiency Testing (PT) documents for 2018, and staff interview, the laboratory failed to enroll in PT testing for 1st and 2nd Events of 2018 for Gynecology (GYN) KOH Prep, and Wet Prep. Findings: 1. Review of the AAB PT documents for 2018, the laboratory did not enroll in PT testing for the 1st and 2nd events for GYN KOH Prep, and Wet Prep. The laboratory did enroll and received and submitted the data for the 3rd event of 2018. In 2017 the laboratory failed to perform PT testing for the 1st and 2nd events for 2017 for GYN KOH Prep and Wet Prep. 2. Interview with the Columbus Health Department District Nurse Manager, and the Columbus Health Department CLIA nurse coordinator, on December 20, 2018, at approximately 3 pm in the Talbot County Health Department conference room, confirmed that they had not participated in the 1st and 2nd events of PT in 2018 for GYN KOH Prep, and Wet Prep. They did 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 -- enroll and participate in the 3rd event of 2018 for GYN KOH Prep, and Wet Prep. **Repeat Deficiency** D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) Proficiency Testing (PT) documents, and staff interview, the laboratory Director failed to ensure that the laboratory was enrolled in a CMS-Approved proficiency test program for Gynecology(GYN) KOH prep and Wet Prep for the First and Second events of 2018. Findings: 1. Review of the AAB PT documents the laboratory failed to enroll in a CMS-approved proficiency testing program for GYN KOH Prep and Wet Prep, for the first and second events of 2018. 2. Interview with the District Health Department Nurse Manager, and District Health Department CLIA nurse coordinator, on December 20, 2018 at approximately 3 pm, in the Talbot County Health Department conference room, confirmed that they were not enrolled in a PT program for the first and second event of 2018 for GYN KOH Prep and Wet Prep.. -- 2 of 2 --