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: Based on desk review of proficiency testing for 2019, the laboratory had unsatisfactory performance for the specialty of hematology, hematology analyte Red Blood Cells, hematology analyte Hematocrit, and hematology analyte Hemoglobin. See D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 proficiency testing for 2019 and the laboratory's graded Proficiency Testing results from College of American Pathologists, the laboratory had unsuccessful performance for the analytes Red Blood Cells, Hematocrit (non-waived), and Hemoglobin (non-waived). Findings include: 1. 2019 first event, analyte - Red Blood Cells, score 60% 2. 2019 first event, analyte - Hematocrit (non-waived), score 60% 3. 2019 first event, analyte - Hemoglobin (non-waived), score 60% 4. 2019 third event, analyte - Red Blood Cells, score 0% 5. 2019 third event, analyte - Hematocrit (non-waived), score 0% 6. 2019 thrid event, analyte - Hemoglobin (non-waived), score 0% D2131 HEMATOLOGY CFR(s): 493.851(g) 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 proficiency testing for 2019 and the laboratory's graded Proficiency Testing results from College of American Pathologists, the laboratory failed to attain an overall testing event score of satisfactory. Findings include: 1. 2019 first event, specialty - Hematology, score 73% 2. 2019 third event, specialty - Hematology, score 0% -- 2 of 2 --