Children's Physicians - Council Bluffs

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the Sysmex XP-300 hematology procedure, Sysmex XP-300 analyzer printouts, patient test reports, quality assessment records and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 4/23/2019, the laboratory failed to establish a written quality assessment policy to monitor, assess, and correct problems related to entering the incorrect medical record number into the Sysmex XP-300 hematology analyzer for three out of three patients in January of 2019. The findings include: 1. The Sysmex XP-300 hematology procedure stated, as part of performing a complete blood cell count (CBC), the testing personnel must "Enter the MRN [medical record number] using the touch keypad." 2. Patient A (identifier MRN XXXX014) had a CBC performed on 1/12/2019. The Sysmex XP-300 printout had the MRN as XXXX015. 3. Patient B (identifier MRN XXXX159) had a CBC performed on 1/23/2019. The Sysmex XP-300 printout had the MRN as 2. 4. Patient C (identifier, MRN XXXX519) had a CBC performed on 1/27/2019. The Sysmex XP-300 printout had the MRN as XXXX520. 5. Quality assessment activities performed in January 2019 did not identify problems related to entering the incorrect medical record number into the Sysmex XP-300 hematology analyzer. 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 review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, hemoglobin, for two consecutive testing events: 2017 event 3 and 2018 event 1 (refer to D2130). 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. 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 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory fails to achieve satisfactory performance for the analyte, hemoglobin, for two consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2017 testing event 3 and 2018 testing event 1. -- 2 of 2 --