Summary:
Summary Statement of Deficiencies 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 chemistry proficiency testing records since the last survey and interview with the General Supervisor (GS) #4, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy of the levetiracetam (keppra) performed on the Beckman Coulter Dx700 AU #1 at least twice annually, since it was put in use for patient testing in March of 2025. Findings include: 1. Review of chemistry proficiency testing records from August 2024 through February 2026 revealed no documentation of proficiency testing for levetiracetam (keppra) performed on the Beckman Dx700 AU #1 to verify accuracy. 2. In an interview on 02/27/2026 at 4:30 p.m. GS #4, listed on the CMS 209 personnel form, confirmed there was no verification of accuracy performed since the installation of levetiracetam (keppra) on March 21, 2025. 3. There was no documentation of accuracy for levetiracetam (keppra) testing performed on the Beckman Coulter Dx700 AU #1 for eleven months of patient testing, from 03/21/2025 through 02/27/2026. Approximately 200 patient samples were tested during this time. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e)(4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to 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 2 -- manufacturer. This STANDARD is not met as evidenced by: Based on lack of documentation of microbiological culture media log records, and interview with General Supervisor (GS) #3, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to document physical characteristics of the media. Findings include: 1. There were no microbiological media log records available for review on the day survey, 2/27/2026. 2. In an interview on 2/27/26 at 11:15 a.m., GS #3 confirmed there was not a mechanism in place to document the physical characteristics of the media or report any deterioration of media to the manufacturer. -- 2 of 2 --