Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 9, 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: Based on review of the American Proficiency Institute (API) records for years 2024 and 2025 and an interview with testing personnel (TP), the lab director failed to attest that proficiency test (PT) samples were tested the same as patient specimens. Findings: 1. Review of API attestations for 2024 (events 1, 2, & 3) and 2025 (events 1 & 2) revealed the lab director did not sign the attestation statements. 2. Interview with TP #1 (CMS Form 209) in the breakroom on December 9, 2025 at 1:03 PM confirmed the finding. 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. This STANDARD is not met as evidenced by: 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 -- Based on review of the Standard Operating Procedure (SOP), Quality Assurance (QA) records, and interview with the testing personnel (TP) the lab director failed to establish a safety standard operation procedure for the eyewash. Findings: 1. Review of the 2024 and 2025 QA records and SOP showed the laboratory lacked an eyewash maintenance procedure. Eyewash logs did not include documented quality checks by testing personnel from July 10, 2025, through December 2, 2025, and the laboratory director did not document review signatures for 2024 or 2025. 2. During a laboratory tour on December 9, 2025, at 3:00 PM, it was identified that the eyewash had been placed on a contaminated sink used for urine disposal. 3. Interview in the laboratory on December 9, 2025, at 3:00 PM, with the back office manager and TP#1 (CMS Form 209) confirmed the laboratory did not meet required eyewash safety and maintenance standards D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on Review of the American Proficency Institute (API) proficiency testing (PT) documents provided and an interview with testing personnel (TP), the laboratory failed to maintain copies of all PT evaluation reports. Findings: 1. Review of API documents provided (submitted results) revealed the laboratory failed to maintain copies of 2024 (events 1,2, and 3) and 2025 (events 1 and 2) evalution reports. NO evaluation reports were provided or on file in the laboratory. No documentation of review was provided. 2. Interview with TP #1 (CMS form 209), in the breakroom, on 12/09/2025, at 1:03 PM confirmed the aforementioned finding. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 Standard Operations Procedure (SOP), observation during the lab tour, and interview with testing personnel (TP) the laboratory failed to adhere to the procedure for processing urine samples. The laboratory lacked procedures for all testing processes in the laboratory. Findings: 1. A Review of the SOP revealed that the testing personnel is to "place urine sample into the centrifuge and spin for 5 minutes." 2. During the laboratory tour, on December 9, 2025, at 3:00 PM, TP #1 (CMS 209 form) was observed in the laboratory stopping the centrifuge before the 5 minute timer was complete. TP #1 (CMS 209 form) was also observed lifting the hood of the centrifuge while it was still spinning, and stopping the centrifuge rotor with her hand. 3. Review of the SOP revealed there was no written policy and procedure for the examination of post vasectomy specimens. 4. Interview with TP#1 (CMS form 209) in the laboratory on December 9, 2025 at 3:00 PM confirmed the aformentioned findings. -- 2 of 5 -- D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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. This STANDARD is not met as evidenced by: Based on Standard Operating Procedure (SOP) review and staff interview, the laboratory failed to maintain manufacturers instructions or follow established written procedures. Findings include: 1. SOP review revealed the laboratory is not following written procedures for Quality Control (QC) of complete urinalysis or the equipment maintenance protocol (no eyewash procedure established). 2. Package inserts were not available to review for QC or Multistix. 3. Interview with the testing personnel (TP) #1 on 12/09/2025 at approximately 1:03 p.m.confirmed the lack of following the laboratory SOP or manufacturers instructions for the aforementioned procedures. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(g) (d)(8) Test control materials in the same manner as patient specimens. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) documents from 2024 and 2025, observation during laboratory tour, and staff interviews, the laboratory failed to monitor the accuracy and precision of complete urinalysis testing over time. Testing personnel did not test urinalysis quality control materials in the same manner as patient specimens. . Findings: 1. Review of the Quality Control documents (Clinitek Thermal Printouts) from January 2024 to December 9, 2025 revealed missing QC log sheets with acceptable reporting ranges. Document review also revealed no urine microscopic QC was being performed. 2. Observation during the laboratory tour revealed 30 of 30 patients had been run without QC aaceptable ranges and without microscopic QC. 3. During an interview, on December 9, 2025, at 1:03 PM in the breakroom, TP#1 (CMS Form 209) confirmed the TP were unaware of the requirement for the log sheets with acceptable ranges or the performance of microscopic urinalysis QC testing. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require