Octapharma Plasma Inc

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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communications with the Proficiency Testing American Association of Bioanalysts (AAB) program personnel; this laboratory failed to successfully participate in the testing of PT samples for Routine Chemistry and Total Protein during events 2 and 3 of 2019. Findings include: Review of CASPER Report 155 and communication with the (AAB) PT provider on 01/08/19 at 10:08 AM, confirmed the initial unsuccessful PT performance under the specialty of Chemistry for PT events 2 and 3 of 2019. See D-2096. 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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communications with the Proficiency Testing American Association of Bioanalysts (AAB) program personnel; this laboratory failed to successfully participate in the testing of PT samples for Routine Chemistry and Total Protein during events 2 and 3 of 2019. Findings include: 1. Review of the CASPER Report 155 on 01/06/2019 at 8:15 AM, revealed that the initial unsuccessful PT performance was under the specialty of Chemistry as listed below. CHEMISTRY Routine Chemistry - EVENT-2, 2019 = 0% Unsat Routine Chemistry - EVENT-3, 2019 = 0% Unsat Total Protein - EVENT-2, 2019 = 0% Unsat Total Protein - EVENT-2, 2019 = 0% Unsat 2. During a phone communication with the (AAB) PT vendor on 01/08/19 at 10:08 AM, confirmed the failing scores under the specialty of Chemistry for PT events 1 and 2 of 2019. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with the quality assurance technician; the laboratory failed to demonstrate precision for total protein testing on Reichert digital refractometers prior to reporting patient test results. Findings Include: 1. Direct observation of laboratory testing equipment on 9-19-2018, at 9:45am, identified 5 Reichert digital refractometers in use total protein testing. Reichert Digital Refractometer Identification Numbers 53879 53905 53907 53908 53909 2. Review of digital refractometer equipment validation documentation for the above mentioned refractometers found no precision documentation for 5 of 5 digital refractometers. 3. Review of non-waived test volume worksheets indicate 29,689 patients were tested for total protein in 2017. 4. On survey date 9-19-2018, at 12:20 pm, the above findings were confirmed by the quality assurance technician. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --