Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1403 Laboratory Director, Moderate Complexity ---------------------------- Laboratory was closed at the time of proficiency testing and has had a change of ownership. 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. 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 -- This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Bacteriology for the analyte Group A Strep (molecular). Refer to D2028. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) records, the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of bacteriology. Findings included: 1. Review of the CMS 0155 report revealed the following results: API 2019 - 2nd Event laboratory received an unsatisfactory score 0% for Group A Strep (molecular). API 2019 - 3rd Event laboratory received an unsatisfactory score of 0% for Group A Strep (molecular). 2. Review of the laboratory's API proficiency testing records revealed the following results: API 2019 - 2nd Event laboratory received an unsatisfactory score 0% for Group A Strep (molecular). API 2019 - 3rd Event laboratory received an unsatisfactory score of 0% for Group A Strep (molecular). 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 a review of proficiency testing records from 2019 (1st, 2nd, and 3rd Events), it was revealed that the laboratory failed to attain an overall testing event score of at least 80% for the 2nd and 3rd testing event of 2019 for Bacteriology resulting in unsuccessful performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: API 2019 - 2nd Event laboratory received an overall unsatisfactory score 0% for Bacteriology. API 2019 - 3rd Event laboratory received an overall unsatisfactory score of 0% for Bacteriology. 2. Review of the laboratory's API proficiency testing records revealed the following results: API 2019 - 2nd Event laboratory received an overall unsatisfactory score 0% for Bacteriology. API 2019 - 3rd Event laboratory received an overall unsatisfactory score of 0% for Bacteriology. 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 desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. 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: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2028. -- 3 of 3 --