Charles Henderson Child Health Center

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on reviews of calibration records for the Beckman Coulter DxH 500 Hematology analyzer, a review of the manufacturer's instructions, a review of Sysmex Insight IQAP (Interlaboratory Quality Assurance Program) Reports, and an interview with the Laboratory Director/ Technical Consultant, the laboratory failed to ensure calibrations were performed as per the manufacturer's instructions to correct for biases noted in the quality control (QC) data. The laboratory further failed to implement a policy specifying the frequency of calibrations. These problems were noted to have occurred from the date of installation of the new analyzer in March 2022 till the date of the survey (8/16/2023). The findings include: 1. A review of the Beckman Coulter DxH 500 Hematology analyzer records revealed the instrument was calibrated during the installation on 3/23/2022. There was no other documentation of calibration until 4 /18/2023 (approximately 13 months later). 2. During an interview 8/16/2023 at 12:15 PM, the surveyor asked the Laboratory Director/ Technical Consultant how often the Beckman Coulter DxH 500 should be calibrated; the Laboratory Director/ Technical Consultant stated the manufacturer does not specify how often calibration was 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 -- required. The surveyor then requested the Beckman Coulter "Instructions for Use Manual". 3. A review of the Beckman Coulter DxH 500 "Instructions for Use Manual", under Chapter 11 Quality Assurance on page 11-1 revealed, "...Calibration... When to Verify Calibration ... ...You should verify the calibration of your instrument ... ...When controls show evidence of unusual trends (all levels demonstrate similar parameter recovery) ...". 4. A review of the Sysmex Insight IQAP reports revealed a positive accuracy bias >2.0 SDI (greater than two Standard Deviation Index) for all three control levels in the MCV (Mean Corpuscular Volume), a Red Blood Cell (RBC) parameter, for the following periods: A) 12/2/2022 - 1/4/2023 for Lot # 22142 B) 3/01 - 4/12/2023 for Lot # 23146 C) 4/12 - 5/26/2023 for Lot # 23147 The only

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on reviews of patient test reports and an interview with the Laboratory Director, the laboratory failed to ensure patient reports included the name and address of the facility performing the testing. This was noted on three of three patient test reports reviewed. The findings include: 1. On 10/21/2021 at 3:05 PM, the surveyor reviewed the post-analytical process in the facility. Upon the surveyor's request, the Laboratory Director provided three final reports from the Office Practicum EHR (Electronic Health Record), as follows: A) Patient A with a CBC (Complete Blood Count) results dated 06/08/2020 B) Patient B with a CBC results dated 10/20/2021 C) Patient C with Urine Colony Count results dated 6/18/2021 2. During an interview on 10/21/2021 at 3:10 PM, the surveyor reviewed the reports with the Laboratory Director who confirmed the above patient tests were performed on-site, however the name and address of the laboratory was not on the reports. The surveyor then asked if this was the report format that is given to patients and outside physicians; the Director confirmed it was. The Director then explained the facility has previously fixed this problem, ensuring the facility name and address were included on the reports. However, when the EHR was undated, the problem recurred, and had not been fixed. SURVEYOR ID #32558 Licensure and Certification Surveyor 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 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 an offsite review of CASPER reports (#153/#155), an on-site review of API (American Proficiency Institute) proficiency testing records, and an interview with Testing Personnel #1 (TP #1), also one of two technical consultants, the surveyor determined the laboratory failed to successfully participate in proficiency testing for RBC (Red Blood Cell Count) for two consecutive testing events. These two failures resulted in the laboratory's initial unsuccessful proficiency testing participation. The findings include: 1. A desk review of the CASPER reports revealed the laboratory failed RBC testing for two consecutive testing events, Event #2 and Event #3 of 2018. 2. The CASPER reports revealed and the API proficiency testing records confirmed 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 -- the laboratory scored zero percent (0 %) for the RBC for Event #2, 2018 and 60 % for Event #3. 3. The above noted failures were discussed with TP #1 (also Technical Consultant), as well as the Laboratory Director on 1/10/2019 at approximately 1:30 PM. 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 an offsite review of CASPER reports (#153/#155), an on-site review of API (American Proficiency Institute) proficiency testing records, and an interview with Testing Personnel #1 (TP #1), also one of two technical consultants, the surveyor determined the laboratory failed to perform satisfactorily in RBC (Red Blood Cell Count) proficiency testing for two consecutive testing events, Event #2 and #3 of 2018. These two failures resulted in the laboratory's initial unsuccessful proficiency testing participation. The findings include: 1. A desk review of the CASPER reports revealed the laboratory failed RBC testing for two consecutive testing events, Event #2 and Event #3 of 2018. 2. The CASPER reports revealed and the API proficiency testing records confirmed the laboratory scored zero percent (0 %) for the RBC for Event #2, 2018 and 60 % for Event #3. 3. The above noted failures were discussed with TP #1 (also Technical Consultant), as well as the Laboratory Director on 1/10 /2019 at approximately 1:30 PM. -- 2 of 2 --