Summary:
Summary Statement of Deficiencies D0000 Based on evidence of unsuccessful proficiency testing performance for the Platelet count analyte, the following Condition level deficiency was deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. . 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 proficiency testing performance review for calendar years 2020 and 2021 (three testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in a proficiency testing program for the platelet count analyte. The laboratory achieved performance scores of forty (40) percent for the third testing event of 2020 and sixty (60) percent for the second testing event of 2021 for the 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 -- platelet count analyte. Based on this evidence the laboratory failed to undertake the appropriate training and/or technical assistance necessary to correct the problem of unsuccessful proficiency testing performance for the platelet count analyte. 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 proficiency testing performance review for calendar years 2020 and 2021 (three testing events), the laboratory failed to achieve satisfactory performance for the same analyte for two out of three proficiency testing events as evidenced by the following: The laboratory achieved performance scores of forty (40) percent for the third testing event of 2020 and sixty (60) percent for the second testing event of 2021 for the Platelet count analyte resulting in unsuccessful performance for the analyte. Refer to D2016. -- 2 of 2 --