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 review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2017 and 2018 proficiency testing performance evaluation reports provided to the surveyor by the laboratory's proficiency testing program, the laboratory failed to maintain satisfactory performance for the hemoglobin analyte in 2017 event three and 2018 event one, resulting in the first unsuccessful occurrence. (Refer to D2130). D2128 HEMATOLOGY CFR(s): 493.851(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- (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 review of the laboratory's proficiency testing performance evaluation reports provided to the surveyor by the laboratory's proficiency testing provider (American Academy of Family Physicians (AAFP)), the laboratory's proficiency testing records, and interview with testing personnel number one, the laboratory failed to obtain appropriate training and employ the technical assistance necessary to correct proficiency testing failures in 2017 and 2018. The findings include: 1. Review of the laboratory's proficiency testing performance evaluation report for 2017 event three revealed unsatisfactory scores for the following analytes as follows: Red blood cell - samples SYX-13 and SYX-14 graded as "Fail" resulting in an overall score of 60%. Hematocrit - sample numbers SYX-13 and SYX-14 graded as "Fail" resulting in an overall score of 60% 2. Review of the laboratory's proficiency testing records revealed no performance evaluation records were available for the 2017 event three, and 2018 event one. 3. Interview with testing personnel number one on May 18, 2018 at 4:00 pm confirmed the laboratory did not have and had not reviewed the performance evaluation reports for 2017 event three, 2018 event one, and failed to perform