Waycross Regional Laboratory

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on observation, review of manufacturer's instructions, lack of temperature /humidity records, and interview with staff, the laboratory failed to ensure the temperature and humidity ranges were within manufacturer's specifications for the operation of 2 of 2 Hologic Panther systems. Findings included: 1. Two Hologic Panther systems (serial numbers 01607 and 01608) were observed during a tour of the laboratory at approximately 1pm on 04/02/2025. 2. The operator manual for the Hologic Panther system states the following on page 198 in Table 91. Environmental Specifications: "Temperature (C) Low Range 15C High Range 30C" "Relative Humidity (%) Low Range 20% High Range 85%" 3. The surveyor requested and did not receive records documenting temperature and humidity levels for the area of the laboratory housing the two Hologic Panther systems. 4. During interview on 04/02 /2025 at approximately 1pm, the Laboratory Director stated temperature and humidity levels were not documented for the area of the laboratory housing the two Hologic Panther systems. 38798 II. Based on review of the DiaSorin Liaison XL User Manual and interview with the Laboratory Manager and the Laboratory Director, the laboratory failed to monitor and document room humidity and room temperature per the manufacturer's instructions for operating one of one DiaSorin Liaison XL 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 -- instrument (serial # 12706). 1. A review of the DiaSorin Liaison XL User Manual, Revision G, 11-2019, page 10-9, Table 10.7 instructed the following environmental condition standards for operating the instrument: Room Temperature range = 15-32C Room Humidity = 10-85% 2. In an interview on April 2, 2025, at 9:55 AM, the Laboratory Manager confirmed the room humidity levels were not monitored and documented for the purposes of operating the DiaSorin Liaison XL instrument used for qualitative antibody testing of Rubeola, Mumps, Rubella and Treponema. 3. In an interview on April 2, 2025, at 10:35 AM, the Laboratory Director confirmed the room temperature was not monitored and documented by the laboratory for the purposes of operating the DiaSorin Liaison XL instrument used for qualitative antibody testing of Rubeola, Mumps, Rubella and Treponema. 4. The total annual test volume for Rubeola, Mumps, Rubella and Treponema antibody testing using the DiaSorin Liaison XL instrument was 3,366. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on observation, record review and interview with staff, the laboratory failed to compare test results for 2 of 2 Hologic Panther Systems twice annually in years 2023 and 2024. Findings included: 1. Two Hologic Panther systems (serial numbers 01607 and 01608) were observed during a tour of the laboratory at approximately 1pm on 04 /02/2025. 2. Review of test comparison records for the two Hologic Panther systems revealed the laboratory performed the following test result comparisons: a. Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis test result comparisons performed 06/07/2023, 06/05/2024 and 12/03/2024. The laboratory failed to perform two test result comparisons in 2023. b. SARS-CoV-2 test result comparisons performed June 2023 and December 2024. The laboratory failed to perform two test result comparisons in 2023 and 2024. 3. During interview on 04/02/2025 at approximately 1:10pm, the Technical Supervisor of Microbiology confirmed the laboratory failed to perform twice a year comparison of test results for the two Hologic Panther systems in 2023 and 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 2/15/2023 - 2/16/2023. The facility was found NOT in compliance with the following 42 CFR Part 493, Requirements for Laboratories for the specialties/subspecialties for which it was surveyed: 493.1240 - Pre-Analytic Systems D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) Plan, QA records and interview with the laboratory director, the laboratory failed to have a written procedure for complaint investigations. Findings include: 1. During record review of the policy titled, "Quality Assessment (QA) Plan" the surveyor found the plan did not include a process for submission of complaint investigations. The QA Plan section titled, "III. Evaluation of the Effectiveness of Policies and Procedures, D. Customer Satisfaction" states, " ... All customer complaints will be documented. The Client Complaint Investigations Form, or some other appropriate form, should be used. Each unit will monitor the number and type of complaints and will be responsible for taking the necessary

Summary Statement of Deficiencies 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 record review of Proficiency Testing (PT) documents for the years of 2017 and 2018 and an interview with the General Supervisor (GS) and Laboratory Director (LD), the laboratory failed to review records ensuring that the analyst performing the testing and the director have signed the statement attesting that PT samples were tested in the same manner as patient specimens. Findings: 1. Review of WSLH PT records revealed that the laboratory failed to ensure that the analyst performing the testing, signed the attestation form for "Blood Lead Combo" for 2017 Events 2 & 3. 2. Review of American Association of Bioanalysts records revealed that the laboratory failed to ensure that the analyst performing the testing, signed the attestation form for "Immunology" for 2017 Event 2 (B). 3. Review of WSLH PT records revealed that the laboratory failed to ensure that the director signed the attestation form for "Blood Lead Combo" for 2017 Events 1, 2 & 3; 2018 Events 1, 2 & 3. 4. Interview with GS and LD on 2/6/19 at approximately 330p, confirmed that the review of PT records had not been performed. 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 -- D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review of competency documents for the years of 2017 and 2018 and an interview with the General Supervisor (GS) and Laboratory Director (LD), the laboratory failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens and annually thereafter. Findings: 1. Review of competency records revealed that 3 out of 3 testing personnel did not have competencies performed for the years of 2017 & 2018. 2. During an interview on 2/6/19 at approximately 3:30p with the GS and LD, it was confirmed that competencies were not performed for the years of 2017 & 2018 for 3 out of 3 testing personnel. -- 2 of 2 --