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: The laboratory failed to achieve overall satisfactory scores for the immunohematolgy analyte ABO group and the subspecialty ABO group and D (Rho) typing for the first and second events 2018 (see D2153 and D2154). This results in the unsuccessful performance in proficiency testing for this analyte and sub specialty. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each 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 -- analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing for 2018, this laboratory had unsatisfactory performance for the analyte ABO typing for the first event 2018 (score 80% ) and for the second event 2018 (score 0% ). D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing for 2018, this laboratory had unsatisfactory overall performance for the sub specialty ABO/D(Rho) typing for the first event 2018 (score 90%) and the second event 2018 (score 0%). -- 2 of 2 --