Summary:
Summary Statement of Deficiencies 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 record review of proficiency testing (PT) records from the College of American Pathologists (CAP) and electronic communication with the laboratory's Administrator (LA), the laboratory failed to successfully participate in two out of two consecutive PT events for partial pressure of carbon dioxide (pCO2) in the subspecialty of Routine Chemistry. This affected two out of two PT testing events completed for the first and second PT events of 2026 resulting in initial unsuccessful PT participation. Findings Include: 1. The laboratory failed to successfully participate 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 -- in two out of two consecutive PT events for pCO2 in the subspecialty of Routine Chemistry for the first and second PT events of 2026 resulting in initial unsuccessful PT participation. (Refer to D2096) 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 record review of proficiency testing (PT) records from the College of American Pathologists (CAP) and an interview with the laboratory's Administrator (LA), the laboratory failed to successfully participate in two out of two consecutive PT events for partial pressure of carbon dioxide (pCO2) in the subspecialty of Routine Chemistry. This affected two out of two consecutive PT events completed for the first and second PT events of 2026 resulting in initial unsuccessful PT participation. Findings Include: 1. Review of the laboratory's CAP documentation, provided on 09 /01/2026 at 3:42 PM via electronic mail (email) from the LA, for the first and second PT events of 2026 found pCO2 was scored 0% (percent). 2. The LA confirmed, on 09 /01/2026 at 3:42 PM via email "Unfortunately our RT who entered the results forgot the decimal points.". 3. The LA confirmed, on 09/18/2026 at 10:58 AM via email, 32 patient pCO2 tests were performed from the third PT event tested on 10/24/2025 (scored 100%) through the second PT event tested on 06/27/2026. RT; Respiratory Therapist -- 2 of 2 --