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: Based on proficiency testing review using the Centers for Medicare and Medicaid (CMS) Casper Report 096 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (2nd event of 2019 and 3rd event of 2019), resulting in the first unsuccessful occurrence for Hematology # 760 including hematocrit(HCT) #785. Findings include: Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Failure to achieve satisfactory performance for the same analyte in two consecutive 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 using the Centers for Medicare and Medicaid (CMS) Casper Report 096 and review of the laboratory's proficiency testing (PT) reports from the American Academy of Family Physicians (AAFP), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2019), resulting in the first unsuccessful occurrence for hematocrit (HCT), analyte # 785. Findings include: 1. Review of Casper Report 096 disclosed the laboratory failed analyte #785 HCT on event 2 of 2019 with a score of 40% and event 3 of 2019 with a score of 60%. 2. Review of the laboratory's proficiency testing reports from AAFP confirms the laboratory failed HCT on events 2 and 3 of 2019, resulting in the first unsuccessful performance. 3. Interview with staff #2 (CMS 209) on 03/30/21 in the lab at approximately 11:30 AM confirmed the 2 consecutive PT failures. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) reports review from the American Academy of Family Physicians (AAFP) and staff interview, the laboratory failed to review unsatisfactory scores and document the