Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory failed to ensure that all the testing personnel (TP) who tested patient samples performed the PT. Findings: 1. The laboratory currently has three TP listed on the "Laboratory Personnel Report" (CMS-209) who perform hematology testing. 2. A review of hematology PT attestation worksheets from five PT events from 2024 through 2025 showed that PT was performed by the same TP (TP #1) in five of five events. 3. During an interview on 10/23/2025 at 1:45 PM, the TC confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. 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: Based on surveyor observation and interview with the technical consultant (TC), the laboratory failed to ensure that a functional eye wash station was located in the laboratory area where testing occurs. Findings: 1. During a tour of the laboratory at 11: 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 -- 10 AM, it was observed that the laboratory had a wall (unplumbed) eye wash station available where testing was performed. 2. Upon inspection, it was observed that the eye wash solution had expired 11/2024. 3. During an interview on 10/23/2025 at 11: 15 AM, the TC confirmed that the eye wash station was expired and not sufficient to protect testing personnel from harm. -- 2 of 2 --