Children's Diagnostic Center

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 --