Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and interview with the laboratory director, the testing person and laboratory director failed to sign attestation statements for two of twelve proficiency testing events in 2020 and 2022. The findings include: 1. Review of the laboratory's proficiency testing records revealed the attestation statements for 2020 hematology event three and 2022 core chemistry event one were not signed by the lab director or testing person. 2. Interview with the lab director on 04/05/22 at approximately 5 p.m. confirmed the lab director and testing person failed to sign attestation statement for two of twelve PT events in 2020 and 2022. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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: The laboratory failed to maintain satisfactory participation in two of three proficiency testing events for the aspartate aminotransferase (AST) analyte (Refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper report 155, the laboratory's 2021 and 2022 proficiency testing (PT) performance evaluation reports, and interview with the laboratory director, the laboratory failed to maintain satisfactory performance for the aspartate aminotransferase (AST) analyte for two of three PT events resulting in the first unsuccessful PT occurrence for the AST analyte. The findings include: 1. Review of the CMS Casper report 155 revealed a score of 60% for the AST analyte for 2021 event two and 2022 event one. 2. Review of the laboratory's 2021 and 2022 PT performance evaluation reports revealed the following: 2021 event two: Sample numbers CH-06 and CH-09 scored as unacceptable resulting in an overall score of 60% for the AST analyte. 2022 event one: Sample numbers CH-04 and CH-05 scored as unacceptable resulting in an overall score of 60% for the AST analyte and the first unsuccessful PT occurrence. 3. Interview with the laboratory director on 04/05/22 at approximately 5 p.m. confirmed the laboratory failed to maintain satisfactory participation in PT for the AST analyte in two of three PT events. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director, the laboratory failed to retain 15 of 27 quality control assay range package inserts for two years in 2022. The findings include: 1. Review of laboratory records revealed the following quality control assay range package inserts were not retained: 15991, 15992, 15993 (chemistry controls) in use on 08/27/20 1351 (Levels 1, 2, and 3) (Complete Blood Count (CBC) QC) in use on 01/20/22 1015 (Levels 1, 2, and 3) -- 2 of 8 -- (CBC QC) in use on 03/08/21 1183 (Levels 1, 2, and 3) (CBC QC) in use on 09/22/21 0297 (Levels 1, 2, and 3) (CBC QC) in use on 11/17/20 2. Interview with the laboratory director on 04/05/22 at approximately 5 p.m. confirmed the laboratory failed to retain quality control assay limit package inserts for two years (15 of 27 lots) reviewed. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to evaluate non-graded proficiency testing (PT) scores for unregulated analytes (Refer to D5213), failed to evaluate non-graded PT scores for regulated analytes (Refer to D5215), failed to verify the accuracy of unregulated analytes twice a year (Refer to D5217), and failed to follow the quality assessment plan for performing