Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate 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 a desk review of proficiency testing (PT) records from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2024 and 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology and the Hematocrit analyte. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 0155 report and API proficiency testing 2024 and 2025 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty of Hematology for the Hematocrit analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2024-3rd Event: The laboratory received an unsatisfactory score of 0% for the Hematocrit analyte. Hematology 2025-1st Event: The laboratory received an unsatisfactory score of 40% for the Hematocrit analyte. 2. A review of the API Proficiency Testing records confirmed the laboratory received the above results. D2131 HEMATOLOGY CFR(s): 493.851(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 0155 report and API proficiency testing 2024 and 2025 records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the specialty of Hematology for two consecutive testing events. Findings included: 1. A review of the CASPER 0155 report revealed the following results: Hematology 2024-3rd Event: The laboratory received an unsatisfactory score of 0% for overall Hematology. Hematology 2025-1st Event: The laboratory received an unsatisfactory score of 78% for overall Hematology. 2. A review of the API proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and API 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 the CASPER 0155 report and API proficiency 2024 and 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-approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --