Summary:
Summary Statement of Deficiencies 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: During a proficiency test desk review on 03/03/2022, based on review of graded reports from Medical Laboratory Evaluation (MLE) and testing personnel interview, the laboratory failed to successfully participate in proficiency testing for bacteriology, the analyte group A streptococcus for two consecutive proficiency testing events (2020, Event M3, and 2021, Event M1). See D2028. D2020 BACTERIOLOGY CFR(s): 493.823(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: During a proficiency testing desk review performed on 03/03/2022, based on review of CASPER Report 0155D and graded reports from Medical Laboratory Evaluation (MLE), it was determined that the laboratory failed to attain an overall testing event score of at least 80% in proficiency testing for the subspecialty bacteriology, the analyte Streptococcus, group A for two consecutive proficiency testing events reviewed (2020, Event M3, and 2021, Event M1). Findings include: 1. Review of graded test results on the CASPER Report 0155D indicated the following proficiency testing scores for your laboratory for the following bacteriology test events: a. 2020, Event M3: Bacteriology, group A streptococcus: 50% b. 2021, Event M1: Bacteriology, group A streptococcus: 50% 2. The scores were confirmed by review of the graded report from MLE. Scores less than 80% for these test events indicate failure or unsatisfactory performance. A failure of the test event for two consecutive or two out of three testing events is scored as unsuccessful. 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: During a proficiency testing desk review performed on 03/03/2022, based on review of CASPER Report 0155D and graded reports from MLE, it was determined that the laboratory failed to achieve satisfactory performance in proficiency testing for the subspecialty bacteriology, the analyte group A streptococcus for two consecutive proficiency testing events reviewed (2020, Event M3, and 2021, Event M1). See D2020. -- 2 of 2 --