Csl Plasma, Inc

Summary Statement of Deficiencies D0000 A desk review for proficiency testing results was conducted by the Pennsylvania State Agency for CSL Plasma, Inc on 08/13/2025. The laboratory was found out of compliance with the following conditions: 493.803 Condition: 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 review of the CASPER 0155 report and graded results from the proficiency testing (PT) organization, American Association of Bioanalysts-Medical Laboratory 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 -- Evaluation (AAB-MLE), the laboratory failed to successfully participate in PT for Total Protein (TP) and the sub-specialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st and 2nd Events of 2025. Refer to D2096 and D2097. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the CASPER 0155D Report and graded results from the proficiency testing organization, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve an overall testing score of satisfactory performance for the routine chemistry analyte: Total Protein (TP) . The laboratory had unsatisfactory scores for the 1st and 2nd events of 2025. Findings include: 1. Review of the CASPER 0155D report revealed the following unsatisfactory scores: - 2025 Event 1 TP: 40% - 2025 Event 2 TP: 0% 2. Further review of the laboratory's 2025 AAB-MLE PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the routine chemistry analyte: TP. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (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 review of the CASPER 0155D Report and graded results from the proficiency testing organization, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve an overall testing score of satisfactory performance for the sub-specialty: routine chemistry. The laboratory had unsatisfactory scores for the 1st and 2nd events of 2025. Findings include: 1. Review of the CASPER 0155D report revealed the following unsatisfactory scores: - 2025 Event 1 TP: 40% - 2025 Event 2 TP: 0% 2. Further review of the laboratory's 2025 AAB-MLE PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the sub-specialty: routine chemistry. . -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager (OM), the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which total protein testing was performed from 02/01/2022 to the date of the survey. Findings include: 1. The PA regulations (5.23 (b)(1)) states: "A general supervisor who meets all the requirements of subsection (a) (1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2. The laboratory performs patient testing Monday through Sunday according to the information in the CMS-116 form (Saturday and Sunday 08:00 to 16:00 and Monday to Friday 07:00 to 19:00). 3. On the day of the survey, 11/07/2023 at 10:46 AM, during an interview, the OM stated that the laboratory did not have a qualified supervisor onsite for every hour of patient testing. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records and interview 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 -- with the office manager(OM), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 1 technical consultant (TC) for their supervisory responsibilities performed in 2022 and 2023. Findings include: 1. On the day of the survey, 11/07/2023 at 10:51 am, a review of laboratory's competency records revealed that the laboratory director (LD) failed to perform a competency assesment for the TC for their supervisory responsibilities performed in 2022 and 2023. 2. The OM confirmed the findings above on 11/07/2023 at 01:05 pm. -- 2 of 2 --