Summary:
Summary Statement of Deficiencies D0000 During a proficiency desk review on 09/13/19, 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 the CMS Form 116 application, 2018-2019 proficiency agency test reports and CASPER Report 155, the laboratory failed to successfully participate in proficiency testing for CBC (Complete Blood Counts). Findings are: A. Review of CASPER Report 155 from the CMS (Centers for Medicare & Medicaid) Proficiency testing database indicated the laboratory received failing scores (0%) for the first two 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 -- events of 2019, 2019-A and 2019-B for the specialty of Hematology resulting in unsuccessful participation in proficiency testing. See D2123 A and D2131 B. Review of AAFP (American Academy of Family Practice) proficiency agency reports for 2018 - 2019 revealed the laboratory failed to participate in the 1st event of 2019 (2019- A). See D2123 B C. Review of the CMS Form 116 application signed by the Laboratory Director and received on 10/29/18 as part of a change of ownership packet revealed no documentation indicating the laboratory had ceased or intended to stop performing CBC testing. See D2123 D D2123 HEMATOLOGY CFR(s): 493.851(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 the review of the 2018 application, 2018-2019 proficiency agency test reports and CASPER Report 155, the laboratory failed to participate in proficiency testing for CBC (Complete Blood Counts) resulting in a score of "0" for the the first 2 test events of 2019. Findings are: A. Review of CASPER Report 155 from the CMS (Centers for Medicare & Medicaid) Proficiency testing database indicated the laboratory received failing scores (0%) for the first two events of 2019, 2019-A and 2019-B for the specialty of Hematology. B. Review of AAFP (American Academy of Family Practice) proficiency agency reports for 2018 - 2019 revealed: 1. Event 2018- C, report dated 11/16/18 The laboratory did not participate in this event. The report indicated, "Not graded - Lab Suspended Testing." The laboratory received a score of 100% for this event. 2. Event 2019-A, report dated 04/18/19 The laboratory did not participate in this event. The report indicated, "Fail - No Results Received." The laboratory received a score of 0% for this event. 3. Event 2019-B, report dated 07/19 /19 did not agree with the CASPER Report 155 results. The laboratory did not participate in this event. The report indicated, "Not graded - Lab Discontinued Testing." The laboratory received a score of 100%. C. Review of the proficiency agency's website revealed the scores for the 3rd event of 2018 (2018-C) were due to the agency no later than 10/30/18. D. Review of the CMS Form 116 application, signed by the Laboratory Director and received on 10/29/18 as part of a change of ownership packet, revealed no indication the laboratory had stopped or intended to stop testing CBCs. 1. Page 1, Section 1 General Information, indicated, "Other changes, ownership & tests." 2. Page 1, Section II Type of Certificate Requested, was marked "Certificate of Compliance." 3. Page 4, Section VIII Non-Waived Testing indicated, "CBC with 3 part differential - Drew 3 Analyzer." D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two -- 2 of 3 -- 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 the 2018 application, 2019 proficiency agency test reports and CASPER Report 155, the laboratory failed to participate in 2 consecutive proficiency test events (2019-A & 2019-B) for CBC (Complete Blood Counts) resulting unsuccessful participation in proficiency testing. Findings are: A. Review of CASPER Report 155 from the CMS (Centers for Medicare & Medicaid) Proficiency testing database indicated the laboratory received failing scores (0%) for the first two events of 2019, 2019-A and 2019-B for the specialty of Hematology. B. Review of AAFP (American Academy of Family Practice) proficiency agency reports for 2019 revealed; 1. Event 2019-A, report dated 04/18/19 The laboratory did not participate in this event. The report indicated, "Fail - No Results Received." The laboratory received a score of 0% for this event. 2. Event 2019-B, report dated 07/19/19 did not agree with the CASPER Report 155. The laboratory did not participate in this event. The report indicated, "Not graded - Lab Discontinued Testing." The laboratory received a score of 100%. -- 3 of 3 --