Alliance Cancer Specialists

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 lack of documentation, record review and interview with the Technical Supervisor (TS), the laboratory failed to established and follow procedures to assess the competency of 4 of 5 Techinical Consultants (TC) for their supervisory responsibilities performed from 08/01/2023 to the date of the survey. Findings Include: 1. On the day of survey, 06/30/2025 at 10:15 am, the laboratory failed to provided a procedure for assessing the competency of the laboratory's technical consultants for their supervisory responsibilities. 2. The laboratory could not provide competency assessment records for 4 of 5 TC (CMS 209 personnel #3,4,5,6) for their supervisory responsibilities performed from 08/01/2023 to 06/30/2025. 3. The TS confirmed the finding above on 06/04/2025 at 10:00 am. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and 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 record review, lack of documentation, and interview with the Technical Consultant (TC), the Laboratory Director failed to ensure that the quality assessment 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 -- (QA) program was established and maintained to assure the quality of the laboratory services provided and to identify failures in quality as they occur for 17 of 17 months from 08/01/2023 to 12/31/2024. Findings include: 1. The laboratory's Laboratory Quality Assurance Plan states," A monthly Quality Assessment checklist will be completed by month end by designated team member: A 'unsatisfactory: results will be forwarded to Laboratory for review, b. Assessment will be dated, signed by the Director and retained for 2 years., c. "Unsatisfactory" results will be addressed and reviewed by all staff members." 2. On the date of survey, 06/30/2025, at 10:30 am, the laboratory failed to provide documentation of the monthly QA performed for 17 of 17 months from 8/1/2023 to 12/31/2024. 3. The TC confirmed the above finding at 10:30 am on 06/30/2025. -- 2 of 2 --

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 review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate in proficiency testing for the analyte White Blood Cell Differential (WBC). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive 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 155 report and graded results from the proficiency testing organization American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate in proficiency testing for the analyte: White Blood Cell Differential (WBC). The laboratory had unsatisfactory scores for the 1st and 2nd event of 2023. Findings include: Analyte Year Event Score WBC 2023 1 27 % WBC 2023 2 16 % -- 2 of 2 --

Summary Statement of Deficiencies 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 the review of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB MLE) Proficiency Testing (PT) records and interview with testing personnel (TP) #4 (CMS 209), the laboratory failed to review and document the

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 Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with the Testing Personnel (TP)#6, the Laboratory Director (LD) failed to sign the MLE PT attestation statement documents for 2 of 3 hematology events in 2020 and 1 of 3 hematology events 2021. Findings include: 1. On the day of survey, 08/10/2021, review of MLE PT records revealed, the following MLE PT attestation statement documents were not signed by the LD: - 2020, Event #2, Hematology - 2020, Event #3, Hematology - 2021 Event #2, Hematology. 2. The TP#6 confirmed the findings above on 08/10/2021 at 10:20 a.m. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manuals and interview with Testing Personnel (TP) #4 and #5, the laboratory failed to establish a Quality Assurance Policy from 2017 to the date of survey. Findings include: 1. On the day of survey, 03 /13/2019, review of the laboratory's manuals revealed that the laboratory could not provide a written policy to assess the quality of its laboratory systems from 08/22 /2017 to 03/19/2019. 2. TP #4 and #5 confirmed the findings above on 03/13/2019 around 10:50 am. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with Testing Personnel (TP) #4 and #5, the laboratory failed to ensure that 3 of 5 boxes of BD Vacutainer Safety-Lok Blood collection set needles were not used beyond their expiration date. Finding Include: 1. On the day of survey, 03/13/2019, while on tour of the laboratory, surveyor #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 2 -- observed, 3 of 5 boxes of BD Vacutainer Safety-Lok Blood Collection Sets, 21 Gauge needles, used to collect patient blood for the Complete blood count (CB) test, had expired: a. Lot Number: 53111 Expiration Date: 07/2018. B. Lot Number: 50511, Expiration Date: 07/2018. ac. Lot Number: 50811, Expiration Date: 09/2018. 2. TO#5 stated the needles were not in use, but could not provide documentation stating the claim. 3. TO #4 and #5 confirmed the above findings on 03/13/2019 around 9:30 am. D5783