Summary:
Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) from 2022 through 2025, the laboratory failed to meet the following conditions, resulting in initial unsuccessful PT participation: D2016 - 42 CFR 493.803 Condition: Successful participation (proficiency testing) D6076 - 42 CFR 1441 Condition: Laboratories performing high complexity testing; laboratory director 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 proficiency testing (PT) desk review of the American Proficiency Institute (API) proficiency testing results, review of the Casper Report 0155D , the laboratory did not successfully participate in a proficiency testing program approved by HHS, for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to participate in the specialty of Routine Chemistry. Refer to D2096 and D2097. 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 Proficiency Testing (PT) desk review of the Casper report 0155D, and the American Proficiency Institute (API) proficiency testing records for 2025, the laboratory failed to achieve satisfactory performance (80% or better) for the same analytes for two out of three consecutive testing events in routine chemistry. Findings include. 1. Review of the Casper 0155D report revealed the following results: 1st event 2025 2nd event 2025 a. ALT = 60% 0% b. AST = 60% 0% c. TBIL = 60 % 0% d. Calcium = 60% 0% e Creatinine = 60% 0% f. Glucose = 60% 0% g. Total Iron = 60% 0% h. LDH = 60% 0% i. Magnesium = 60% 0% j. Potassium = 60 % 0% k. Sodium = 60 % 0% l. Total Protein = 60 % 0% m. BUN = 60% 0% n. Uric Acid = 60% 0% 2. A review of the API proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the Casper 0155D report and American Proficiency Institute 2025 records (1st and 2nd events), the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the subspecialty of Routine Chemistry. Findings include: 1. A review of the Casper 0155D report revealed the following: a .1st event Routine Chemistry = 72% b. 2nd event Routine Chemistry = 0% 2. A review of API proficiency testing record for 2025 confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of Casper 0155D report and American Proficiency Institute 2025 records, the laboratory director failed to provide overall -- 2 of 3 -- management and directionof the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provide. Refer to 6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Casper 0155D report and American Proficiency Institute 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approve proficiency testing program. Refer to D2096 and D2097. -- 3 of 3 --