Waggoner Pediatrics Of Central Iowa

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, platelets, for two consecutive testing events: 2022 testing event 3 and 2023 testing event 2 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. 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, platelet, for two consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2022 testing event 3 and 2023 testing event 2. -- 2 of 2 --

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment (QA) policy, lack of QA records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 01/30/2020, the laboratory director failed to ensure that the laboratory established and followed a QA policy that describes the system or process for monitoring the general, pre-analytic, analytic, and post-analytic quality systems as well as define the frequency of QA monitoring. The findings include: 1. The laboratory's QA policy stated, "We will perform a quality review on a periodic basis to review results with the laboratory director or technical consultant for their approval." 2. Personnel identifier #2 stated that QA monitoring activities had not been performed since the last survey on 02/08/2018. 3. At the time of the survey, personnel identifier #2 confirmed that the QA policy did not include the process for monitoring the quality systems or the frequency with which they would be monitored. 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 --