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 review of competency assessment records and interview with testing personnel #2 (TP), the laboratory failed to establish a procedure to assess the competency of 4 of 5 clinical consultants for their supervisory responsibilities in 2020 and 2021. Findings include: 1. On the day of survey, 10/05/2022 at 10:20 am, TP #2 could not provide a procedure for the competency assessment for 4 of 5 CC (CMS 209 personnel # 11,12, 13, and 14) for their supervisory responsibilities in 2020 and 2021. 2. No documentation was provided that competency assessments were performed for 4 of 5 CC for their supervisory responsibilities from 2020 to the date of survey. 3. TP #2 confirmed the findings above on 10/05/2022 around 12:00 pm. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the Sysmex XN-430 analyzer validation records and interview with testing personnel # 2 (TP), the laboratory failed to establish criteria for acceptable performance specifications for 12 of 12 analytes performed on the Sysmex XN-430 analyzer from 12/14/2020 to the date of survey. Findings Include: 1. On the day of survey, 10/05/2022 around 10:14 am, review of the Sysmex XN-430 analyzer validation records revealed that the validation performed on 10/28/2020 did not include the laboratory's acceptable criteria for performance specifications for precision, accuracy, and reportable ranges for the following analytes: - White Blood Count (WBC) - Red Blood Count (RBC) - Hemoglobin (HGB) - Hematocrit (HCT) - Mean Corpuscular Volume (MCV) - Mean Corpuscular Hemoglobin (MCH) - Mean Corpuscular Hemoglobin Concentration (MCHC) - Platelet (PLT) -Mean Platelet Volume (MPV) -Red Blood Cell Distribution Weight (RDW) - Neutrophils (NEU) - Lymphocytes (LYM) 2. TP #2 confirmed the findings above on 10/05/2022 around 12: 00 pm. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of personnel qualification records and interview with Testing Personnel #2 (TP)., the laboratory failed to have a technical consultant who meets the qualification requirements for hematology testing (moderate complexity) from 07/09 /2021 to the date of survey. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or -- 2 of 3 -- biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of personnel qualification records, competency assessment (CA) records and interview with testing personnel #2 (TP), the laboratory failed to have a Technical Consultant (TC) who meets the qualification requirements for hematology testing (moderate complexity) from 07/09/2021 to the date of survey. Findings include: 1. On the date of survey, 10/05/2022 at 10:20 am, review of CA records revealed that TP#2 performed competency review and observation, and signed off on the CA records for 2 of 9 TP in 2021 (CMS 209 personnel #5,9) and 7 of 9 TP in 2022 (CMS personnel #1,3,4,5,6,8,9) for hematology examinations. 2. Review of the CMS 209 personnel form signed by the Laboratory Director (LD) on 10/05/2022 listed the LD as the only TC. No documentation was provided for delegation of duties. 3. Further review of TP #2's education credentials revealed, TP #2 is a medical assissant which does not meet the minimal educational qualifications under C.F.R. 493.1411 to perform technical consultant responsibilities for moderate complexity testing in hematology . 4. 51,576 complete blood counts (CBC) were performed in 2021. (CMS 116 annual test volume) 5. TP#2 confirmed the findings above on 10/05/2022 around 12:00 pm. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory's procedure manuals, review of competency assessment records and interview with testing personnel #2 (TP), the Technical Consultant (TC) failed to evaluate and document the performance of 1 of 9 testing personnel (TP) responsible for performing hematology examinations for their semi-annual competency from 09/28/2020 to the day of survey. Findings include: 1. On the day of survey, 10/05/2022 at 10:15 am, the laboratory was unable to produce the semi-annual competency assessment records for 1 of 9 TP (CMS 209 personnel #7) that performed hematology examinations from 09/28/2020 to 10/05/2022. 2. The laboratory performed 51,576 complete blood count (CBC) tests in 2021 (CMS-116 annual test volume). 3. TP#2 confirmed the above findings 10/05/2022 around 12:00 pm. -- 3 of 3 --

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), 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) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), 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 event of 2021, and 3rd event 2021. Findings include: Analyte Year Event Score WBC 2021 1 0% WBC 2021 3 20% -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory maintenance record, and interview with the Medical Assistant (MA), the laboratory failed to retain maintenance records for 2 of 2 Beckman Coulter ACT Diff-2 analyzers from 2018. Findings include: 1. On the day of survey, 09/28/2020, the laboratory could not provide maintenance records for 2 of 2 Beckman Coulter ACT Diff-2 analyzers from 02/28/2018 to 09/28/2018. 2. The MA confirmed the above finding on 09/28/2020 around 09:15 am. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory Quality Assessment (QA) policy, quality assessment records and interview with Medical Assistant (MA), the laboratory failed to retain 3 of 12 quality assessments review records from 2018. Findings include: 1. The laboratory QA policy states "quality assessment factors will be reviewed monthly and documented on the quality assessment work sheet". 2. On the day of survey, 09/28 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- /2020, the laboratory could not provide the quality assessment review records for 3 of 12 months in 2018 (February, March and April). 3. On 09/28/2020 at 09:30 am, the MA confirmed the finding above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based upon review of the Quality Control (QC) policy, Beckman Coulter ACT Diff-2 QC records and interview with the Medical Assistant (MA), the laboratory failed to perform and document calibration at least once every 6 months, for 2 of 2 Beckman Coulter ACT Diff-2 Analyzers in 2018 and 2019. Findings include: 1. The laboratory QC policy states, "Calibration will be performed every 06 months using S-CAL calibrator for routine maintenance". 2. On the day of survey, 09/28/2020, review of 2 of 2 Beckman Coulter ACT Diff-2 records revealed, calibrations were not performed at least every 6 months on the following analyzers in 2018 and 2019. -Infusion room location: Performed once in 2018 (08/22/2018). -Laboratory area: Performed once in 2018 (08/23/2018). Performed once in 2019 (03/12/2019). 3. On 09/28/2020 at 10:10 am, the MA confirmed the findings above. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter ACT Diff-2 Analyzers records and -- 2 of 3 -- interview with the Medical Assistant (MA), the laboratory failed to evaluate the relationship between 2 of 2 Beckman Coulter ACT Diff-2 analyzers used for Complete Blood Count (CBC) analysis in 2018, 2019, 2020. Findings include: 1. On the day of survey 09/28/2020, review of the Beckman Coulter ACT Diff-2 records revealed, the laboratory did not perform comparison studies on 2 of 2 Beckman Coulter ACT Diff-2 CBC analyzers in 2018, 2019 and 2020. 2. On 09/28/2020 at 10: 15 am, the MA confirmed the findings above. -- 3 of 3 --