Waycross Urology Clinic

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 23, 2024. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. CONDITION LEVEL CITATIONS: D2016 493.803 (a)(b) (c) Successful Participation D6000 493.1403 Moderate Complexity Laboratory Director NOTE: The CMS-2567 (Statement of Deficiencies) is an official , legal document,. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 14, 2020. 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: 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 observation by the surveyor during a tour of the laboratory and staff interview, the laboratory failed to perform maintenance and function checks on the Omano Microscope and the VanGuard V6000 centrifuge used to prepare specimens for testing. Findings include: 1. Observation by the surveyor during a tour of the laboratory revealed no documentation that the rotations per minute (RPM) check on the centrifuge has been performed. **Repeat Deficiency** 2. Observation by the surveyor during a tour of the laboratory revealed no documentation that the Omano Microscope has annual maintenance performed on it. 3. Interview with the office manager on January 14, 2020 at approximately 1230 pm in her office, confirmed there is no documentation of microscope or centrifuge maintenance and RPM check is not performed annually as required. 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 19, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, review of patient testing records and staff interview, the laboratory failed to rotate performance of proficiency testing samples among all personnel who test patient samples. Findings include: 1. Review of PT attestation statements and PT testing records revealed all PT samples in 2016, 2017 and 2018 were tested by testing personnel # 3 (see CMS 209). 2. Review of patient testing records revealed testing personnel #1 (See CMS 209) began testing patient samples in September 2016. 2. Interview with testing personnel #1 (see CMS 209) on March 19, 2018 at 11 am confirmed testing personnel # 3 performed testing on all PT samples in 2016, 2017 and 2018. . 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) attestation statements and staff interview, both the laboratory director and testing personnel failed to sign attestation statements in 2016, 2017 and 2018. Findings include: 1. Review of AAB PT attestation statements for 2016, 2017 and 2018 revealed they are not signed by the testing personnel performing the testing or the laboratory director. 2. Interview with testing personnel # 1 (see CMS 209) on March 19, 2018 at 11 am confirmed attestation statements are not signed. D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of records to review and staff interview, the laboratory failed to meet requirements for quality control, maintenance and function checks, calibration and calibration verification, proficiency testing and Laboratory Director in the subspecialty of Endocrinology when performing Prostate Specific Antigen (PSA) testing. Findings include: D5221, D 5429, D5431, D5439, D5445, D 5481, D5783 D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records, review of the laboratory's PT records showing the value obtained and staff interview, the laboratory failed to take