Cpn, Inc Dba Ah Levine Children's Arboretum

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 2025 CAP (College of American Pathologists) proficiency testing results, the laboratory failed to successfully participate in proficiency testing for Hematocrit on 2 of 3 consecutive test events in 2025. 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 -- (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 Casper reports 153D and 155D and 2025 CAP proficiency testing results, the laboratory failed to achieve satisfactory performance for the analyte Hematocrit on 2 of 3 consecutive testing events, resulting in unsuccessful performance. Findings: 1. Review of CMS Casper reports revealed the following scores: a. 2025 Event 1 = 40% b. 2025 Event 3 = 40% 2. Review of CAP proficiency testing results for these events confirmed the above scores. 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 Casper reports 153D and 155D and 2025 CAP proficiency testing results, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 Casper reports 153D and 155D and 2025 CAP proficiency testing results, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of Centers for Medicare & Medicaid Services (CMS)-209, and review of College of American Pathologists (CAP) proficiency testing (PT) records for 2019, 2020 and 2021 8/17/21, the laboratory failed to ensure PT was performed by testing personnel (TP) who routinely perform hematology testing. Findings: Review of CMS-209 submitted at time of survey revealed 12 TP routinely perform hematology testing. Review of laboratory procedure "Proficiency Testing" revealed "Proficiency Testing Participation:...Proficiency Testing is required for every moderately complex test. 1. For moderately complex tests, you receive five samples three times a year. That means you will receive 15 samples over a year's time....3. Per CLIA, 11-07, one person must run all five samples in that shipment." The procedure fails to ensure all TP who routinely perform hematology testing have the opportunity to participate in PT as required. Review of 2019, 2020 and 2021 CAP PT records revealed 1 TP (5 of 12 TP) participated in each of 5 PT events; the 3rd event of 2019, the 1st, 2nd and 3rd events of 2020 and the 1st event of 2021. 7 of 12 TP did not participate in the 5 PT events. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When 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 -- control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of 2020 hematology quality control (QC) records 8/17/21 and email correspondence with technical consultant (TC) 8/19/21, the laboratory failed to use the manufacturer's established QC values for the ActDiff hematology analyzer from 5 /1/20 until 8/8/20, a period of approximately 3 months. Findings: Review of 2020 hematology QC records revealed the laboratory began using Lot #067500, 077500 and 087500 on 5/1/20. Review of QC records for Lot #067500, 077500 and 087500 revealed the laboratory entered the QC values established for the ActDiff2 hematology analyzer. Email correspondence with TC at approximately 3:30 p.m. confirmed incorrect QC values were entered. She also confirmed the laboratory uses an ActDiff hematology analyzer to perform testing. -- 2 of 2 --