Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on November 5, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 the findings herein, the Condition: Successful Participation (in a proficiency testing program) was not met. A review of the federal database CASPER Report 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 -- 0155D and email confirmation from the laboratory on November 14, 2024, found that the laboratory failed to successfully participate in a proficiency testing (PT) program. Findings include: The laboratory failed to maintain successful participation with the College of American Pathologists (CAP) PT program shown by the unsuccessful performance for hematocrit in the second and third PT events of 2024. Refer to D2121. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the federal database CASPER Report 0155D and email confirmation from the laboratory on November 14, 2024, , the laboratory failed to successfully participate in a proficiency testing (PT) program. Findings include: 1. The laboratory failed to maintain successful participation with the College of American Pathologists (CAP) PT program shown by the unsuccessful performance for hematocrit in the second and third PT events of 2024. 2. Both the CASPER Report 0155D and the CAP PT evaluation reported a score of 60% for the second PT event of 2024 and 40% for the third PT event of 2024. 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 the findings herein, the Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director was not met. A review of the federal database CASPER Report 0155D and email confirmation from the laboratory on November 14, 2024, found that the laboratory director failed to ensure successful participation in a proficiency testing (PT) program. Findings include: The laboratory director failed to ensure successful participation with the College of American Pathologists (CAP) PT program shown by the unsuccessful performance for hematocrit in the second and third PT events of 2024. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the federal database CASPER Report 0155D and email confirmation from the laboratory on November 14, 2024, , the laboratory director failed to ensure successful participation in a proficiency testing (PT) program. Findings include: 1. The laboratory director failed to ensure successful participation with the College of American Pathologists (CAP) PT program shown by the unsuccessful performance for hematocrit in the second and third PT events of 2024. 2. Both the CASPER Report 0155D and the CAP PT evaluation reported a score of 60% for the second PT event of 2024 and 40% for the third PT event of 2024. -- 3 of 3 --