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 a review of the CASPER Report 155 and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analytes: Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALK), Aspartate Aminotransferase (AST), Total Bilirubin, Calcium, Chloride, Total Cholesterol, Creatinine, Glucose, Potassium, and Sodium. The laboratory had unsatisfactory scores for the 2nd event of 2018 and the 3rd event of 2018. See D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 the CASPER Report 155 and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analytes: Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALK PHOS), Aspartate Aminotransferase (AST), Total Bilirubin, Calcium, Chloride, Total Cholesterol, Creatinine, Glucose, Potassium, and Sodium. The laboratory had unsatisfactory scores for the 2nd event of 2018 and the 3rd event of 2018. Findings include: 1. AAB 2018 Event 2 for ALT the score was 0%. 2. AAB 2018 Event 3 for ALT the score was 0%. 1. AAB 2018 Event 2 for Albumin the score was 0%. 2. AAB 2018 Event 3 for Albumin the score was 0%. 1. AAB 2018 Event 2 for ALK PHOS the score was 0%. 2. AAB 2018 Event 3 for ALK PHOS the score was 0%. 1. AAB 2018 Event 2 for AST the score was 0%. 2. AAB 2018 Event 3 for AST the score was 0%. 1. AAB 2018 Event 2 for Total Bilirubin the score was 0%. 2. AAB 2018 Event 3 for Total Bilitubin the score was 0%. 1. AAB 2018 Event 2 for Calcium the score was 0%. 2. AAB 2018 Event 3 for Calcium the score was 0%. 1. AAB 2018 Event 2 for Chloride the score was 0%. 2. AAB 2018 Event 3 for Chloride the score was 0%. 1. AAB 2018 Event 2 for Total Cholesterol the score was 0%. 2. AAB 2018 Event 3 for Total Cholesterol the score was 0%. 1. AAB 2018 Event 2 for Creatnine the score was 0%. 2. AAB 2018 Event 3 for Creatinine the score was 0%. 1. AAB 2018 Event 2 for Glucose the score was 0%. 2. AAB 2018 Event 3 for Glucose the score was 0%. 1. AAB 2018 Event 2 for Potassium the score was 0%. 2. AAB 2018 Event 3 for Potassium the score was 0%. 1. AAB 2018 Event 2 for Sodium the score was 0%. 2. AAB 2018 Event 3 for Sodium the score was 0%. -- 2 of 2 --