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 10/02/2020. 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 desk review of federal database CASPER Report 155D and interview with the laboratory manager on 9/30/2020 at approximately 4:00 PM, the laboratory did 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 -- not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the first and second testing events of 2020 with a score of 0% in each event resulted in unsuccessful proficiency testing performance for bacteriology. Findings include: The laboratory failed to maintain successful participation with the American Proficiency Institute (API) proficiency testing ( PT) program shown by the unsuccessful performance for bacteriology in the first and second testing events of 2020. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 desk review of federal database CASPER Report 155D and interview with the laboratory manager on 9/30/2020 at approximately 4:00 PM, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the first and second testing events of 2020 with a score of 0% in each event resulted in unsuccessful proficiency testing performance for bacteriology. Findings include: 1. CASPER Report 155D reviewed showed the laboratory scored 0% for the first and second testing events of 2020 for bacteriology. 2. The laboratory manager interviewed on 9/30/2020 at approximately 4:00 PM indicated that the laboratory did not participate with the proficiency testing program for bacteriology for the first and second events of 2020. 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 desk review of federal database CASPER Report 155D and interview with the laboratory manager on 9/30/2020 at approximately 4:00 PM, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the first and second testing events of 2020 with a score of 0% in each event resulted in unsuccessful proficiency testing performance for bacteriology. The Condition: Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1407. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. Refer to D6016. -- 2 of 3 -- 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: Based on desk review of federal database CASPER Report 155D and interview with the laboratory manager on 9/30/2020 at approximately 4:00 PM, the laboratory director failed to ensure that proficiency testing samples were tested as required. Findings include: 1. The laboratory failed to achieve satisfactory performance for bacteriology in the first and second testing events of 2020 resulting in unsuccessful PT performance. 2. CASPER Report 155D reviewed reported 0% scores for bacteriology for the first and second testing events of 2020. 3. The laboratory manager interviewed on 9/30/2020 at approximately 4:00 PM indicated that the laboratory did not participate with the API proficiency testing program for the first and second events of 2020. -- 3 of 3 --