Synergy Hematology Oncology

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records from AAB for the years 2021 and 2022, and interview with the laboratory technical consultant on March 27, 2023, at 12:45 pm, the laboratory failed to return the WBC differential results to AAB for the Q1 PT event of 2021. The findings include: 1. The laboratory participated in the AAB PT testing program in 2021 for its CBC test. The laboratory received the Q1 PT sample; however, it did not return or report the WBC differential results to AAB. The laboratory received a "0" score for the WBC differential test. Therefore, the accuracy of the reported WBC differential test results to patients during the Q1 PT event cannot be assured and may have harmed patients. 2. The laboratory technical consultant on March 27, 2023, at 12:45 pm, affirmed that the laboratory did not return the PT testing results to AAB and received a "0" score at the Q1 event in 2021. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/2/2023 stated that the laboratory performs approximately 25,920 tests, annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step 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 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the second quarter (Q3-2019) of the American Association of Bioanalysts (AAB) proficiency testing records, ten (10) random patient test results from 01//03/2019 to 10//21/2020 and interview with the technical supervisor, it was determined that the laboratory failed to participate in a testing event is unsatisfactory performance and results in a score of 0% for the testing event. The findings included: 1. The CLIA Casper Report 0096D and AAB Q3-2019 proficiency event reported an unsatisfactory score of 0% for the Hematology performance summary of Q3-2019, which included: Erythrocyte (RBC), Hemoglobin (HGB), Hematocrit (HCT), Leukocyte (WBC) count, Platelet count, White Blood (WBC) Differential. Also, the laboratory policies and procedure manual, under Proficiency Testing Policy, "Upon receiving PT samples, laboratory will': Items 1 through 8 were not followed. 2. The technical superior affirmed 10/22/2019 11:45 a. m. (survey date) that laboratory failed to submit the proficiency challenges for AAB Q3-2019. 3. The laboratory's testing declaration (10/20/2020) reported 28,800 hematology patient tests performed (annually). 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 -- 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 the surveyor's observation, examination of laboratory reagents, patient test reports covering the period from 01/03/ 2019 to 10/ 21/2020, and interview with the laboratory technical supervisor (TS), it was determined that the laboratory failed not to use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, 10/2/2020 at approximately 11:00 a.m. the examiner found in the phlebotomy basket expired vacutainer test tubes (Trace Element Serum vacutainer test tube, Lot 9126535, expiration date of 2020-05-31, PTT Plasma preparation vacutainer test tube K2E, Lot 9065694, expiration date 20-03-31, Sodium Heparin vacutainer test tube, Lot 8187715, expiration date 2019-11-30). 2. The technical superior affirmed on 10/22/2020 at 11:45 a.m. that the vacutainer test tubes had exceeded their expiration dates and the quality and reliability of the patients test results were in question. -- 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performance. (See D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, WBC DIFF, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, WBC DIFF, as follows: 2019 Q1 2019 Q3 WBC DIFF 73% 0% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, WBC DIFF. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, WBC DIFF, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2130) -- 2 of 2 --