Summary:
Summary Statement of Deficiencies D0000 A Proficiency Testing (PT) Desk Review survey was completed on 5-13-2026. The following condition-level deficiency was found to be out of compliance: D2016- 42 C. F.R. 493.803 Condition: Successful participation (proficiency testing) D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on PTDR of the CASPER report 0155D, PT scores from API, and phone interview with Laboratory Manager (SP-1) on 5/06/26 at 2:08pm, the laboratory failed to achieve satisfactory performance in two consecutive PT events (Event 3/2025 and Event 1/2026) for the analyte, Creatinine in the Subspecialty of Rout Chem Refer to D2096. The laboratory failed to achieve overall satisfactory scores in the Subspecialty 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 -- of Rout Chem for PT Events 3/2025 and Event 1/2026. Refer to D2097. Legend: API =American Proficiency Institute CASPER= Certification and Survey Provider Enhanced Reporting PT= Proficiency testing PTDR= Proficiency testing desk review Rout Chem= Routine Chemistry SP= staff personnel D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on PTDR of the CASPER report 0155D, PT scores from API, and phone interview with Laboratory Manager (SP-1) on 5/06/26 at 2:08 pm, the laboratory failed to achieve satisfactory performance in two consecutive PT events (Event 3 /2025 and Event 1/2026) for the analyte, Creatinine. Findings include: 1) Review of the Casper Report 0155D indicated proficiency testing failures for the following events /analyte: Subspecialty Analyte Event Score Rout Chem Creatinine 3/2025 60% Rout Chem Creatinine 1/2026 60% 2) In a phone interview on 5/06/26 at 2:08 pm, SP-1 confirmed the API PT scores for unsatisfactory performance for Creatinine. 3) Review of API Performance Summary for 2026 Chemistry- Core- 1st Event confirmed unsuccessful scores for Creatine Event 3 2025 60%, and Event 1 2026 60%. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on PTDR of the CASPER report 0155D, PT scores from API, and an interview with the Laboratory Manager (SP-1) on 5/06/26 at 2:08 pm, the laboratory failed to achieve satisfactory performance for two consecutive PT testing events (Event 3/2025 and Event 1/2026) in the Subspecialty of Rout Chem and the Specialty of Chemistry. Findings include: 1) Review of CASPER Report 155D indicated unsatisfactory overall scores in Rout Chem. (Refer to D2096) 2) A phone interview with SP-1 on 4 /06/26 at 2:08pm confirmed the failing scores for Rout Chem. 3) Review of API Performance Summary for 2026 Chemistry- Core- 1st Event confirmed unsuccessful scores for the Specialty Chemistry and the subspecialty Rout Chem for Event 3 2025 60%, and Event 1 2026 60%. -- 2 of 2 --