Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the national database and verified with the PT company. The laboratory 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 proficiency testing (PT) desk review of the Certification and Survey 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 -- Provider Enhanced Reporting-0155 and American Proficiency Institute 2023 (3rd Event) and 2024 (2nd Event) records, the laboratory failed to successfully participate in a PT program. The laboratory failed to successfully participate in the specialty of Hematology for Cellular Identification or White Blood Cell Differential for 2 out of 3 testing events. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2023 (3rd Event) and 2024 (2nd Event) records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in 2 out of 3 testing events in Hematology for Cellular Identification or White Blood Cell Differential (Cell ID or WBC Diff). The findings include: 1. Review of the CASPER -0155 report revealed the following: Hematology 2023- 3rd Event Laboratory received an unsatisfactory score of 72% for Cell ID or WBC Diff. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 60% for Cell ID or WBC Diff. 2. A PT desk review from API 2023 and 2024 PT records confirmed the above findings. 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. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2023 (3rd event) and 2024 (2nd event) records, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of Cellular Identification or White Blood Cell Differential testing during 2 out of 3 testing events. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2023 (3rd Event) and 2024 (2nd Event) records, the laboratory director failed to ensure that the PT samples were tested as required under Subpart H during 2 out of 3 testing events. Refer to D2130. -- 3 of 3 --