Children's Diagnostic Center

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . 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 proficiency testing desk review from the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and the laboratory's American Proficiency Institute (API) 2025 and 2026 Proficiency Testing (PT) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in PT for the analyte Hematocrit (HCT). Refer to D2130. . D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a PT desk review of the CASPER 0155 report and the laboratory's API PT records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the HCT analyte for two of three consecutive testing events. The findings include: 1. A review of the CASPER 0155 report revealed the following results: -A score of 0% for the HCT analyte for 2025 Event Two -A score of 60% for the HCT analyte for 2026 Event One 2. A review of the laboratory's API PT records confirmed the above findings. . 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 a proficiency testing desk review of the CASPER 0155 report and the American Proficiency Institute 2025 and 2026 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure PT samples were tested as required. 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 a PT desk review of the CASPER 0155 report and the API 2025 and 2026 records, the laboratory director failed to ensure PT samples were tested as required. The laboratory director failed to ensure successful participation in an HHS-approved PT program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, and staff interview, the laboratory failed to label three of three CBC control vials with a corrected expiration date after opening. The findings include: 1. Observation of the laboratory on 06/12/24 at 09:30 a.m. revealed the Beckman Coulter DxH 520 CBC instrument (SN BD050366) used for performing patient testing for CBC w/Diff. The controls (three of three) were labeled with an open date of 06/05/24 but no corrected expiration date. Lot numbers observed were 352416011, 352416012 and 352416013. 2. A review of the manufacturer package insert revealed the controls were stable for 16 days after opening. 3. The practice manager, lab manager and testing personnel confirmed the survey findings during interview on 06/12/24 at 12:15 p.m. 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 D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5303 TEST REQUEST CFR(s): 493.1241(b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. This STANDARD is not met as evidenced by: Based on a review for five of five patient records and an interview with the Technical Consultant (TC), the laboratory failed to obtain written or electronic orders of laboratory tests for three of five charts for a complete blood cell (CBC) test ordered within 30 days of testing during 2017-2019. Findings include: 1. A records review for 3 of 5 patient charts revealed no order or requisition for a CBC test on patient #1 (#170108, 10-13-2017), patient #4 (#168930, 9-14-18), and patient #5 (# 164086, 7- 26-2019) that were reported during 2017-2019. 2. An interview on August 14, 2019, at 12:45pm, with the TC confirmed no written or electronic order for a CBCs analyzed for a patient #1 (#170108, 10-13-2017), patient #4 (#168930, 9-14-18), and patient #5 (# 164086, 7-26-2019) that were reported during 2017-2019. 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 a review of the Centers for Medicare Services personnel report (CMS 209), review of the laboratory's employee competency evaluations and upon interview with 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 technical consultant (TC), determined the Technical Consultant failed to perform and document a semi-annual competency evaluations for testing personnel #5 and #6 who began laboratory testing in August and April 2019, respectively. The findings include: 1. Review of the CMS 209 revealed 6 of 6 testing personnel reporting in Hematology for complete blood count (CBC) for 2017-2018 with two new testing personnel in April and August 2019. 2. A review of the laboratory's semi-annual competency evaluations for testing personnel #5 and #6 who began laboratory testing in August and April 2019, respectively, in Hematology for complete blood count (CBC) did not reveal the TC's signature/approvals. 3. An interview with the TC at approximately 12:30pm, at August 14, 2019, confirmed that semi-annual competency evaluations were missing the TC's signature/approvals for testing personnel #5 and #6 who began laboratory testing in August and April 2019, respectively, in Hematology for complete blood count (CBC). D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare Services personnel report (CMS 209), review of the laboratory's employee competency evaluations and upon interview with the technical consultant (TC), determined the Technical Consultant failed to perform and document annual competency evaluations for testing personnel #1 (2018 missing), #2, #3, and #4 for 2017-2018. The findings include: 1. Review of the CMS 209 revealed 6 of 6 testing personnel reporting in Hematology for complete blood count (CBC) for 2017-2018. 2. A review of the laboratory's annual competency evaluations for testing personnel #1 (2018 missing), #2, #3, and #4 for 2017-2018 in Hematology for complete blood count (CBC) did not reveal the TC's signature /approvals. 3. An interview with the TC at approximately 12:30pm, at August 14, 2019, confirmed that annual competency evaluations were missing the TC's signature /approvals for testing personnel #1 (2018 missing), #2, #3, and #4 for 2017-2018 in Hematology for complete blood count (CBC) for 2017-2018. -- 2 of 2 --