Summary:
Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted on 1/10/20 for the the Metromedic Walk In Medical Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of unsuccessful proficiency testing performance for the Blood Urea Nitrogen analyte, the following Condition level deficiency was deemed to be not met: Condition 42 CFR 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 proficiency testing review for calendar year 2019 (three testing events), the 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 -- laboratory failed to successfully participate (achieve a score of 80 percent or more) in the American Association of Bioanalysts (AAB) proficiency testing program for the Blood Urea Nitrogen analyte. The laboratory achieved a score for Blood Urea Nitrogen of zero (0) percent (failure to participate - refer to D2089) for the first testing event of 2019 and forty (40) percent for the third testing event of 2019. Based on this evidence the laboratory failed to undertake effective training and/or technical assistance necessary to correct the problem of unsuccessful proficiency testing performance for the Blood Urea Nitrogen analyte. . 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 record review of calendar year 2019 proficiency testing results (three testing events), the laboratory failed to attain an overall testing event score of at least 80 percent leading to unsatisfactory performance. Findings showed that for the Blood Urea Nitrogen analyte the laboratory received a testing event score of zero (0) percent (failure to participate - refer to D2089) for the first testing event of 2019 and forty (40) percent for the third testing event of 2019 leading to unsatisfactory performance for each of the two testing events. . D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review of calendar year 2019 proficiency testing results (three testing events), the laboratory failed to return proficiency testing results for the first event of 2019 as evidenced by the following: a) A review of the the American Association of Bioanalysts (AAB) proficiency testing results for the first testing event of 2019 revealed that the laboratory received a score of zero (0) percent for all chemistry analytes for failure to participate. b) The laboratory's failure to participate in the first testing event of 2019 was confirmed through a telephone interview on 1/9/20 with the laboratory technologist and the the American Association of Bioanalysts (AAB) proficiency testing program. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) -- 2 of 3 -- 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 proficiency testing review for calendar year 2019 (three testing events), the laboratory failed to achieve satisfactory performance for the Blood Urea Nitrogen (BUN) analyte. The laboratory achieved a score of zero (0) percent (failure to participate - refer to D2089) for the first testing event of 2019 and a score of forty (40) for the third testing event of 2019 resulting in unsuccessful performance. Refer to D2016. -- 3 of 3 --