Alliance Cancer Specialists

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Laboratory Personnel Report (CLIA) CMS-209, Competency Assessment records and interview with Technical Consultant (TC), the TC failed to evaluate and document the annual competency of 1 of 3 Testing Personnel (TP) who performed Hematology (Complete Blood Count) testing from 06/21/2022 to date of survey. Findings include: 1) On the day of survey 09/14/2023 at 9:25 am, a review of Competency Assessment records and interview with TC revealed TP #2 (CMS-209) was hired in February of 2022 and began testing patient specimens for Complete Blood Count (CBC) using Sysmex XN-450 analyzer on 06/21/2022. 2) At the time of survey, the laboratory could not provide documentation of the annual competency assessment performed for TP #2 upon request by the surveyor. 3) On 09/14/2023 at 10: 35am TC confirmed the annual competency was not performed for TP#2. 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 --

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 laboratory procedure manuals and interview with the Technical Supervisor (TS)#2, the laboratory failed to establish a complete competency assessment procedure to assess the competency of 1 of 2 Technical supervisors, 1 of 1 Technical Consultant (TC), and 1 of 1 General Supervisor (GS) for 2019, 2020 and 2021. Findings Include: 1. On the day of survey, 10/06/2021, the laboratory could not provide a written procedure to assess the competency of 1 of 2 TS (CMS 209 personnel #2), 1 of 1 TC, and 1 of 1 GS for Hematology patient testing from 10/06 /2019 to 10/06/2021. 2. The TS#2 confirmed the finding above on 10/06/2021 around 10:45 a.m. 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 Technical Supervisor (TS) #2, the laboratory failed to establish a maintenance policy to assess the maintenance/function for 1 of 1 unlabeled thermometer used to monitor the 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 -- temperature for the refrigerator use for the storage of quality controls (QC) for the Sysmex XN450 analyzer and 1 of 1 Thermo Fisher Scientific digital thermometer for room temperature in hematology for 2019, 2020 and 2021. Findings Include: 1. On the day of survey, 10/06/2021, the laboratory could not provide a maintenance policy for the thermometers. 2. The laboratory could not provide maintenance records for 1 of 1 unlabeled thermometer used to store quality control materials for the Sysmex XN450 analyzer. 3. An expiration date of 03/28/2016 was observed on the sticker posted on the Thermo Fisher Scientific digital thermometer for room temperature. 4. TS #2 confirmed the findings above on 10/06/2021 at 11:25 a.m. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) record review and interview with the Technical Supervisor, the laboratory failed to test PT peripheral smear Cell Identification samples for (PT events performed between (07/27/2017 and 04/18/2019), with personnel who routinely performed the peripheral smear Cell Identification in the Laboratory. Findings include: 1. Only medical providers routinely performed peripheral smear Cell Identification. 2. Review of the PT attestation statements, revealed only Testing Personnel who do not routinely perform peripheral smear Cell Identification , performed and and signed the attestation statements for (07/27/2017 and 04/18/2019). 3. 4 of 4 medical providers failed to participate in PT for peripheral smear Cell Identification from (07/27/2017) and 04/18/2019). 4. During the survey (13:30 04/18/2019), the Technical Supervisor confirmed the above findings. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on review of the competency records and interview of the Technical Supervisor, at the time of survey (13:30 04/18/2019), the Technical Supervisor failed to document the competency of all testing personnel who performed peripheral blood smear Cell Identification,. from 07/26/2017 to 04/18/2019. Findings include: 1. On the date of the survey (04/18/2019), the laboratory failed to provide documentation of annual competency for 3 of 4 testing personnel, who performed peripheral blood smear Cell Identification. 2. During the survey (13:30 04/18/2019), the Technical Supervisor confirmed above finding. -- 2 of 2 --