Grace Hematology & Oncology

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 2023 and 2024 hematology records, the absence of background records, and interview with testing personnel (TP) #3 on 8/15/24, the laboratory failed to retain DxH 500 hematology analyzer background counts for approximately 19 months from 1/26/23 to 8/15/24. Findings: Review of 2023 and 2024 hematology records revealed the laboratory started using the new DxH 500 hematology analyzer 1 /26/23. The laboratory failed to retain background counts for the DxH 500 since the analyzer was put into use, a period of approximately 19 months. During interview at approximately 11:06 a.m., TP #3 stated the lab does not print backgrounds. 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 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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of 2020 and 2021 API(American Proficiency Institute) PT (proficiency testing) records, review of 2020 and 2021 hematology calibration records, and interview with TP(testing personnel #1) 2/28/22, the laboratory failed to test PT samples in the same manner it tests patients specimens for 3 of 3 PT events in 2021. Findings: Review of 2021 API PT records revealed 2021 Hematology /Coagulation 1st event was submitted 3/26/21, 2nd event was submitted 7/22/21, and 3rd event was submitted 11/11/21. Review of 2021 Hematology calibration records revealed the laboratory calibrated the Beckman Coulter AcT Diff analyzer on 3/19/21, 7/21/21, and 11/11/21. During interview at approximately 12:30 p.m., TP #1 confirmed she makes sure the analyzer is calibrated before she runs proficiency testing. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 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 manufacturer's operators manual, review of 2020 and 2021 hematology calibration records and the absence of documentation 2/28/22, the laboratory failed to retain all required Coulter AcT diff hematology calibration records. Findings: Review of the Beckman Coulter AcT Diff Operator's manual revealed for Auto-Calibration, "...3b. At the Setup screen, touch the Setup Report icon to print the old calibration factors...14. After 11 acceptable sample results, the Summary icon appears, touch the icon to view the summary screen. If Autoprint is ON and you are using a graphic printer a summary report prints automatically....Print the new calibration factors and place them in your log book...." 1. Review of Coulter AcT diff 2020 and 2021 calibration records revealed the laboratory failed to retain copies of all records for the following calibrations: a. 4/7/20: no documentation for the calibration summary with results of calibration and the S-cal calibrator assay sheet for the lot number used; b. 5/19/20: no documentation for the calibration summary with the results of calibration and the S-cal calibrator assay sheet for the lot number used; c. 8/25/20: no documentation for the new calibration factors printed post-calibration; d. 3/19/21: no documentation for the new calibration factors printed post-calibration and no S-cal calibrator assay sheet for the lot number used; e. 7/21/21: no documentation for the new calibration factors printed post-calibration; f. 11/11/21: no documentation for the new calibration factors printed post-calibration and no S-cal calibrator assay sheet for the lot number used. 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 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 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/1/20, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) differential in two consecutive testing events. See the deficiency cited at 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 3 -- 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/1/20, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) differential in two consecutive testing events. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory received a score of 60% for granulocytes % and a score of 40% for monocytes/mids %, resulting in a score of 67% for WBC differential on the 2019 Hematology 3rd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 60% for granulocytes % and a score of 20% for monocytes/mids %, resulting in a score of 60% for WBC differential on the 2020 Hematology 1st event. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/1/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/1/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory received a score of 60% for granulocytes % and a score of 40% for monocytes/mids %, resulting in a score of 67% for WBC differential on the 2019 Hematology 3rd event. 2. Desk review of CMS Casper report -- 2 of 3 -- 155D and 2020 API proficiency testing results revealed the laboratory received a score of 60% for granulocytes % and a score of 20% for monocytes/mids %, resulting in a score of 60% for WBC differential on the 2020 Hematology 1st event. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2018 and 2019 Temperature and humidity logs, the absence of documentation, and interview with TP (Testing Personnel) 9/11/19, the laboratory failed to monitor and document the conditions required for accurate and reliable test performance. Findings: Random review of 2018 and 2019 temperature and humdity logs revealed refrigerator temperature, room temperature, and room humidity were not documented for the following: 1. November 2018 - 5 of 19 days with no refrigerator temperature documentation (11/26-11/30); 2. March 2019 - 4 of 20 days with no room temperature documentation (3/11-3/15); 3. April 2019 - 2 of 21 days with no refrigerator, room temperature, or room humidity documentation (4/8-4 /9); 4. May 2019 - 4 of 23 days with no refrigerator temperature documentation (5/27- 5/30); During interview at approximately 2:15pm, TP #1 confirmed the missing temperature documentation was overlooked. 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 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of 2019 hematology quality control (QC) records and observation, the laboratory failed to discard control materials and supplies that had exceeded the expiration date. Findings: 1.) Random review of 2019 hematology QC revealed the Coulter 4C-ES cell control lot numbers 068800, 078800, and 088800 expired on 3/25 /19, and was in use 3/26/19, 3/27/19, 3/28/19, 3/29/19, and 4/1/19. 65 patients were tested between 3/26/19-4/1/19. During tour of laboratory at approximately 2pm, the surveyor observed the following expired supplies, that were available for use: 2.) a. Hemocue hb 201 microcuvettes, lot #1704201, expired 7/9/18. b. Royal Blue BD Vacutainer Trace Element Serum blood tube, lot #7279890, expired 10/31/18. c. Royal Blue BD Vacutainer Trace Elements K2EDTA blood tube, lot #8011601, expired 1/31/19. d. Pink BD Vacutainer K2EDTA blood tube, lot #7305676, expired 4 /30/19. 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