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 record review and interview with laboratory (lab) staff, the lab did not have attestation statements for the second proficiency test event of 2018 for troponin (cardiac kit), and the second proficiency test event of 2018 for lactic acid (blood gas kit). Findings: 1. The lab enrolls in proficiency testing with an approved proficiency test provider, and three times a year during enrollment, the provider mails the lab five samples (these samples are unknowns and the concentration of the analytes is not provided to the lab). The lab performs the tests and submits the results to the provider to evaluate for accuracy. Prior to testing, the lab director and the testing staff must sign an attestation statement that the proficiency test samples are tested in the same manner as patient samples; 2. In 2018 the lab did not have records showing that the analyst signed attestation statements for the troponin and lactic acid tests for the second events in 2018; and 3. This was confirmed during interview with lab staff on the day of survey. 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, 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 -- 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 the laboratory's proficiency test records and interview with staff, the laboratory (lab) performed unsuccessfully on proficiency testing for lactic acid and troponin in 2019. See D2096 for findings. 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 record review and interview, the laboratory's proficiency testing performance was unsuccessful for both troponin and lactic acid in 2019. Findings: 1. The laboratory obtained a score of 0% on proficiency testing for lactic acid (blood gas kit) on the 3rd event in 2018 and the 1st event in 2019; 2. The laboratory obtained a score of 0% on proficiency testing for troponin (cardiac kit) on the 1st and 2nd events in 2019; 3. During interview with lab staff, it was determined that the lab did not receive the proficiency test kits from the receiving department at their facility and obtained scores of 0% due to the fact that the proficiency testing was not performed; and 4. At the time of the survey, the lab has not implemented