Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) attestation statements for 2016-2018 and confirmed by laboratory personnel, identifier #2 (refer to Laboratory Personnel Report) at approximately 10:30 am on 05/22/2018, the laboratory failed to maintain a copy of the attestation statement signed by the laboratory director and testing personnel for three out of six PT testing events. The findings include: 1. The laboratory director did not sign the attestation statements for the following testing events: *2017-Event 3: Hematology; and *2018-Event 1: Hematology. 2. The laboratory failed to have the attestation statement for 2016-Event 3: Hematology. THIS IS A REPEAT DEFICIENCY. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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: 2017 event 3 and 2018 event 1; and the analyte, automated white blood cell differential, for two out of three consecutive testing events: 2017 event 2 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. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, platelets, for two consecutive testing events and for the analyte, automated white blood cell differential, for two out of three testing events for unsuccessful participation. The findings include: 1. The laboratory received unsatisfactory performance scores of 60 percent (%) for 2017 testing event 3 and 2018 testing event 1 for platelets. 2. The laboratory received unsatisfactory performance scores of 50% for 2017 testing event 2 and 2018 testing event 1 for automated white blood cell differential. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records for 2016-2018 and confirmed by the laboratory personnel, identifier #2 (refer to the Laboratory Personnel Report) at 11:45 am on 05/22/2018, the laboratory failed to verify the accuracy of the urine microscopy twice annually for three out of four time periods from June 2016 through May 2018. The findings include: 1. The laboratory records revealed that the laboratory verified -- 2 of 5 -- the accuracy of the urine microscopy on 06/09/2016. The laboratory failed to have verification records for 2017 and 2018. 2. The laboratory personnel confirmed that the laboratory failed to verify the accuracy of the urine microscopy in 2017 and 2018. THIS IS A REPEAT DEFICIENCY. D5783