Summary:
Summary Statement of Deficiencies D0000 A Proficiency Testing (PT) Desk Review survey was completed on 4.17.2026. The following condition-level deficiencies were 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 155D from the (CMS) data system, API Performance Summary, and an email from the Laboratory Manager (SP-1) on 4/06 /26, the laboratory failed to achieve satisfactory performance in two consecutive testing events (Event 3/2025 and Event 1/2026) resulting in unsuccessful participation for analytes; pH and pCO2. Refer to D2096 The laboratory failed to achieve overall 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 -- satisfactory scores in the Subspecialty of Rout Chem for Event 3/2025 and Event 1 /2026. Refer to D2097. Legend: API= American Proficiency Institute CMS= Centers for Medicare and Medicaid Services pH = potential of hydrogen pCO2 = partial pressure of carbon dioxide 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 155D from the CMS data system, API Performance Summary, and an email from the Laboratory Manager (SP-1) on 4/06 /26, the laboratory failed to achieve satisfactory performance in two consecutive testing events (Event 3/2025 and Event 1/2026) resulting in unsuccessful participation in the Subspecialty of Rout Chem for analytes; pH and pCO2. Findings include 1) Review of the Casper Report 155D indicated proficiency testing failures in the following events for the following analytes: Subspecialty Analyte Event Score Rout Chem pH 3/2025 60% Rout Chem pH 1/2026 40% Rout Chem pCO2 3/2025 60% Rout Chem pCO2 1/2026 60% 2) Review of API reports indicated unsatisfactory performance in Routine Chemistry for analytes; pH (potential of hydrogen) and pCO2 (partial pressure of carbon dioxide). 3) In an interview (via email) on 4/06/26 at 2:18 pm, SP-1 confirmed the above scores for pH and pCO2. Legend: API= American Proficiency Institute CMS= Centers for Medicare and Medicaid Services pH = potential of hydrogen pCO2 = partial pressure of carbon dioxide PTDR= Proficiency testing desk review Rout Chem= Routine Chemistry SP= staff personnel 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 155D from the (CMS) data system, API Performance Summary, and an email from the Laboratory Manager (SP-1) on 4/06 /26, the laboratory failed to achieve satisfactory performance in two consecutive testing events (Event 3/2025 and Event 1/2026) resulting in unsuccessful participation in the Subspecialty of Rout Chem. Findings include: 1) Review of CASPER Report 155D indicated unsatisfactory overall scores in Rout Chem for the following events: Subspecialty Event Score Rout Chem 3/2025 78% Rout Chem 1/2026 60% 2) An email received on 4/06/26 at 2:18 pm, by SP-1 provided a "self- reporting" proficiency test document that confirmed the failing scores for Routine Chem. -- 2 of 2 --