Summary:
Summary Statement of Deficiencies D0000 An unannounced onsite complaint survey was performed on October 23rd, 2025, and the laboratory was found to NOT be in compliance with the CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1250 Analytic Systems 493.1441 Laboratory Director, (high complexity) 493.1447 Technical Supervisor The complaint was substantiated. The laboratory's failure to be in compliance with the CLIA regulations was found to pose immediate jeopardy to the patients served by the laboratory. D3007 FACILITIES CFR(s): 493.1101(b) (b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policy, and confirmed in interview, the laboratory failed to supply appropriate and sufficient equipment for patient analysis for one of one specialty (microbiology) in October 2025. Findings included: 1. During a tour of the laboratory on 10/23/2025 at 03:25 PM, the surveyor observed two pipettes in the Post-PCR sample processing area. Further observations revealed the laboratory did not possess the correct pipette tips for the observed pipettes. 2. Review of laboratory policy, "Pipette Policy" (Approved by the laboratory director on 05/07/2024) revealed the following: " ...Purpose: This procedure is to classify and describe the use of pipettes/pipettors used for clinical laboratory assays. Standard practice at this laboratory is to use pipettes for the reconstitution of reagents, standards, and controls, to use automatic pipettors for specimen dilutions and pretreatments ..." 3. In an interview on 10/23/2025 at 03:29 PM in the laboratory Post- PCR room, testing person one (TP-1) stated the observed pipettes were not in use. TP- 1 further stated the in-use pipettes were sent to another laboratory location and were not currently available for testing. This confirmed the laboratory failed to supply Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- appropriate and sufficient equipment for patient analysis for one of one specialty (microbiology) in October 2025. Word Key PCR- Polymerase Chain Reaction D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare and Medicaid Services (CMS)-209 form, laboratory policy, personnel records, and confirmed in interview, the laboratory failed to have a policy in place for technical supervisor competency evaluation for 20 of 20 months in 2024 and 2025 (01/2024-09/2025). Findings included: 1. Review of CMS- 209 form during the survey process on 10/23/2025, revealed one laboratory personnel documented as performing technical supervisor (TS-1) responsibilities. 2. Review of laboratory policy manual revealed the laboratory failed to have a policy in place for technical supervisor competency evaluations. The surveyor requested a specific policy pertaining to technical supervisor competency evaluations, and none was provided. 3. Review of personnel records revealed no documentation of competency evaluations for TS-1 in 2024 and 2025. 4. In an interview on 10/23/2025 at 12:15 PM, in the facility office area, testing person one (TP-1) was asked to provide documentation of competency for TS-1 in 2024 and 2025. TP-1 stated all documentation available was provided. This confirmed the laboratory failed to have a policy in place for technical supervisor competency evaluation for 20 of 20 months in 2024 and 2025 (01/2024-09 /2025). D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory American Proficiency Institute (API) Proficiency Testing (PT) records in 2025, laboratory policy, and confirmed in interview, the laboratory failed to have documentation of verifying the accuracy of microbiology analytes not scored by the PT program for two of two events in 2025. Findings included: 1. Review of API PT records in 2025, revealed the following: "Proficiency Evaluation Proficiency Testing Microbiology 2025 ... ... Laboratories are responsible for documenting and performing