Summary:
Summary Statement of Deficiencies 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: Revisit 02/19/2019 through 02/20/2019 New condition level deficiency. Based on review of the CMS 155 report and College of American Pathologists (CAP) proficiency testing (PT) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the blood gas analyte pO2. Refer to D2096. D2088 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Revisit 02/19/2019 through 02/20/2019 New deficiency. Based on review of CMS 155 report, College of American Pathologists (CAP) proficiency testing (PT) records and in interview with staff, the laboratory failed to attain an overall testing event score of at least 80% for the specialty of chemistry for 1 of 3 events in 2018 (2018-1). Findings included: 1. Review of the CMS 155 report for the laboratory's PT scores 2018-1 revealed an overall testing event score of at least 80%, as follows: Event 1 - Routine Chemistry 36% 2. Review of CAP PT records for chemistry 2018 - 1 revealed an overall testing event score of 36%. 3. During an interview on 02/20/2019 at 5:00 pm, the Technical Consultant and Testing Person -2 confirmed the above 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: Revisit 02/19/2019 through 02/20/2019 New deficiency. Based on review of CMS 155 report, College of American Pathologists (CAP) proficiency testing (PT) records and in interview with staff, the laboratory failed to achieve satisfactory performance (80% score or greater) for the same analyte in two out of three testing events in the specialty of chemistry for the analyte pO2. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings included: 1. Review of the CMS 155 report for the laboratory's PT scores in 2018 (Events 1 and 3) revealed unsatisfactory scores, as follows: Event 1 - pO2 0% Event 3 - pO2 60% 2. Review of CAP PT records for blood gases in 2018 revealed the following for Event 1 and 3 (AQ-A, AQ- C): Event 1 - PT company original evaluation included code "[24] = Incorrect response due to failure to provide a valid response" (04/10/2018). The scores for pH, pO2, and pCO2 were 0% (Unsatisfactory).