Clinical Lab - Cellular Therapy

Summary Statement of Deficiencies 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 with the Technical Supervisor (TS) (CMS 209), the laboratory failed to establish a procedure to assess the competency of 1 of 1 TS, 1 of 1 General Supervisor (GS) and 1 of 4 Testing Personnel (TP) #1 (CMS 209) for their supervisory and testing responsibilities in flow cytometry in 2022 and 2023. Findings include: 1. On the day of survey, 09/26/2023 at 12:58 PM, the laboratory could not provide competency assessment records for the following personnel for their supervisory and testing responsibilities in flow cytometry laboratory 2022 and 2023: - 1 of 1 TS -1 of 1 GS - 1 of 4 TP 2. The TS confirmed the findings above on 09/26/2023 at 14:30 PM. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) Proficiency Testing (PT) Performance Evaluation records and interview with Technical Supervisor (TS) (CMS- 209) the laboratory failed to document a

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the laboratory service manager, the laboratory failed to perform maintenance/ function checks on 2 of 2 Sorval centrifuges in 2020. Findings Include: 1. On the day of survey, 10/05/2021, observation of the laboratory revealed , 2 of 2 sorval RC 3BP Plus centrifuges service stickers stated, "maintenance due on 12/2020". - H1: 41259558 - H2: 41259557 2. The laboratory could not provide maintenance records performed on the centrifuges after 12/2020. 3. The laboratory service manager confirmed the findings above on 10 /05/2021 around 9:50 am. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing records and interview with the technical supervisor (TS), the laboratory failed to obtain signatures of testing personnel and the laboratory director on the attestation statement forms in 2017. Findings include: 1. On the day of survey, 04/10/2019, review of CAP proficiency testing attestations forms revealed, in 2017, Flow Cytometery events #1,2 and 3 were not signed by the testing personnel performing testing and by the laboratory director. 2. The TS confirmed the finding above on 04/10 /2019 around 9:30 am. 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: A. Based on review of Laboratory procedure manuals and interview with the technical supervisor (TS), the laboratory failed to establish a complete procedure on how to assess the competency of 1 of 1 TS and general supervisor (GS) from 2017 to the date 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 -- of survey. Findings include: 1. On the day of survey, 04/10/2019, the laboratory failed to provide a complete written policy that reviews how to assess the competency of 1 of 1 personnel (CMS 209 Laboratory Personnel Report, is listed as the TS and GS) from 2017, 2018 and 2019. 2. The TS confirmed the findings above on 04/10/2019 around 09:15 am. B. Based on review of Laboratory procedure manuals, review of testing personnel competency assessment records and interview with the technical supervisor (TS), the laboratory failed to establish a complete procedure on how to assess the competency of testing personnel performing Flow Cytometry testing from 2017 to the date of survey. Findings include: 1. On the day of survey, review of the laboratory's "Staff Education/Training Plan/ Staff Performance and Competence Assessment Plan", revealed the procedure did not include how to assess the 6 points of personnel competency for TP performing Flow Cytometry testing. 2. In 2017, 2 of 5 (TP # 3 and 4) did not perform in the assessment of test performance through blind testing or proficiency testing. 3. In 2018, 1 of 5 (TP # 2) did not perform in the assessment of test performance through blind testing or proficiency testing. 4. The TS confirmed the findings above on 04/10/2019 around 9:30 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the procedure manuals and interview with the technical supervisor, the laboratory director failed to ensure a quality assessment (QA) programs were established and maintained from 2017 to the day of survey. Findings Include: 1. On the day of survey, 04/10/2019, the TS could not provide documentation of QA activities performed to assess the laboratory's pre-analytic, analytic and post analytic phases of testing from September of 2017 to March of 2019. 2. The TS mentioned QA activities were performed but could not provide documentation on 04 /10/2019 around 10:45 -- 2 of 2 --