Summary:
Summary Statement of Deficiencies D0000 During a proficiency desk review on May 7, 2018, the laboratory was found out of compliance with the following condition: 42 CFR Part 493.803 Proficiency Testing, Successful Participation 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 the review of 2017-2018 Proficiency reports from the proficiency testing agency and Centers for Medicare & Medicaid Services database, the laboratory failed to successfully participate in proficiency testing for the analyte sodium. Findings are: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 1. The laboratory failed 2 of 3 test events for the analyte sodium. See D2094 2. The laboratory must obtain training and/or technical assistance to investigate the cause of the failures. See D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of 2017-2018 Proficiency reports from the proficiency testing agency and Centers for Medicare & Medicaid Services database, the laboratory received unsatisfactory scores for the analyte sodium. Findings are: 1. Review of the proficiency scores reported to the Centers for Medicare & Medicaid database, the laboratory received a score of 0% for the 2nd event of 2017 and the 1st event of 2018. 2. Review of the proficiency testing reports from the proficiency testing agency confirmed this finding. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the review of 2017-2018 Proficiency reports from the proficiency testing agency and Centers for Medicare & Medicaid Services database, the laboratory failed to successfully participate in proficiency testing for the analyte sodium and must obtain training and/or technical assistance to investigate the cause of the failures.. Findings are: 1. Review of the proficiency scores reported to the Centers for Medicare & Medicaid database, the laboratory received a score of 0% for the 2nd event of 2017 and the 1st event of 2018. 2. Review of the proficiency testing reports from the proficiency testing agency confirmed this finding. 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 the review of 2017-2018 Proficiency reports from the proficiency testing agency and Centers for Medicare & Medicaid Services database, the laboratory failed -- 2 of 3 -- 2 of 3 test events for the analyte sodium. Findings are: 1. Review of the proficiency scores reported to the Centers for Medicare & Medicaid database, the laboratory received a score of 0% for the 2nd event of 2017 and the 1st event of 2018. 2. Review of the proficiency testing reports from the proficiency testing agency confirmed this finding. -- 3 of 3 --