Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of reagent package insert, review of operator's manual for the Clinitex Status, lack of documentation and interviews with technical consultant (TC) and nursing staff 11/13/25, the laboratory failed to follow manufacturer's instructions for the performance of urinalysis testing on the Clinitex Status. At approximately 10:30 a.m. surveyor observed two Clinitex Status analyzers in the nursing station at the facility. Surveyor also observed a nurse performing testing on the one of the Clinitex Status analyzers utilizing the Siemens Multistix 10 SG Reagent Strips. 1. The laboratory failed to monitor and document the temperature and humidity of the nursing station. Findings: a. Review of package insert for the Siemens Multistix 10 SG reagent strips revealed "STORAGE:...Store at temperatures between 15-30 C (59-86F).". b. Review of operator's manual for the Clinitex Status revealed under Specifications, "Ambient Operating Temperature Range 18C to 30C (64F to 86F) and Ambient Operating Humidity Range 18% to 80% Relative Humidity.". c. Review of laboratory records revealed no documentation the laboratory had monitored the temperature and humidity of the nursing station. 2. The laboratory failed to perform quality control (QC) as required for the Siemens Multistix 10 SG reagent strips. Findings: a. Review of package insert for the Siemens Multistix 10 SG reagent strips revealed "QUALITY CONTROL:...Test positive and negative quality controls with new lots, new shipments of reagents, and when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days.". b. Review of laboratory records revealed no documentation the laboratory had performed quality control as required. Interview with a nurse at approximately 10:45 a.m. confirmed the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- nurses perform urinalysis testing on the Clinitex Status analyzer. Interview with TC at approximately 10:45 confirmed the nurses perform urinalysis testing on the Clinitex Status analyzer. They stated they perform the testing every day. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of Clinical Laboratory Improvement Amendment (CLIA) certificate database, review of 2024 and 2025 laboratory records, lack of documentation and interview with technical consultant (TC) 11/13/25, the laboratory failed to verify the accuracy of the urine microscopic and semen analysis testing at least twice annually since the provider performed microscopy procedure( PPMP) testing began in August of 2024. Findings: Review of CLIA certificate database revealed the laboratory's CLIA certificate was changed to a PPMP certificate August of 2024 and then changed to a certificate of compliance in March of 2025. Review of 2024 and 2025 laboratory records revealed no documentation of a verification of accuracy for urine microscopic and semen analysis (PPMP) testing. Interview with TC at approximately 12:15 p.m. confirmed the laboratory had no documentation of a verification of accuracy for the urine microscopic and semen analysis (PPMP) testing. She stated she was not responsible for the testing performed by the providers. 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 laboratory policy, review of 2025 Sciteck proficiency testing (PT) results, and interview with technical consultant (TC) 11/13/25, the laboratory failed to perform and document