Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . I. Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2017, 2018 and 2019, confirmed by staff interview, the laboratory director failed to attest to the routine integration of samples into the patient workload using the laboratory's routine methods. Findings: a. Review of API PT documentation for testing in hematology revealed the laboratory director failed to sign the attestation statements for the 3rd testing event of 2017 and the first testing event of 2018. b. In an interview at the site on 06-13-2019, testing person 1 (CMS form 209) confirmed that the forms were unsigned. She stated she had become involved in proficiency testing in late 2018 when the previous principal testing person had retired. II. Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2017, 2018 and 2019, confirmed by staff interview, the testing person failed to attest to the routine integration of samples into the patient workload using the laboratory's routine methods. a. Review of API PT documentation for testing in hematology revealed the person performing the testing failed to sign the attestation statement for the first testing event of 2018. b. In an interview at the site on 06-13-2019, testing person 1 confirmed that the form was unsigned. Refer to I b above. . D2121 HEMATOLOGY CFR(s): 493.851(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. 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 -- This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2017, 2018 and 2019, confirmed by staff interview, the laboratory failed to attain a satisfactory score for hematology analyte White Blood Cell differential count (WBC diff) in the third testing event of 2018. Findings: 1. Review of API PT documentation for hematology testing revealed the following scores: Hematology 3rd event 2018 Granulocytes (%) Sample Reported Expected Score HEM-11 69.7 70.1-73.7 Unacceptable HEM-12 81.2 80.3-85.6 Acceptable HEM-13 84.3 82.5-85.8 Unacceptable HEM-14 63.8 68.6-73.1 Acceptable HEM-15 45.0 41.8- 49.4 Acceptable Analyte score: 60% Lymphocytes (%) Sample Reported Expected Score HEM-11 26.5 21.4-26.2 Unacceptable HEM-12 13.5 10.1-13.6 Acceptable HEM-13 12.7 11.1-14.0 Acceptable HEM-14 32.0 22.4-27.5 Unacceptable HEM-15 51.6 44.9-55.0 Acceptable Analyte score: 60% The unacceptable scores for Granulocytes (%) and Lymphocytes (%) combined to yield a score for analyte WBC diff of 73%. 2. In an interview at the site on 06-13-2019, testing person 1 confirmed the unacceptable scores. . D2128 HEMATOLOGY CFR(s): 493.851(e) (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 API PT documentation for 2017,2018 and 2019, confirmed by staff interview, the laboratory failed to take appropriate action to correct problems associated with unsatisfactory performance in hematology. Findings: 1. Review of API PT documentation revealed unsatisfactory performance for analyte WBC diff in the third testing event of 2018. Refer to D2121. 2. Review of API PT documentation revealed unsatisfactory performance for analyte Granulocytes (%) in the third testing event of 2018. Refer to D2121. 3. Review of API PT documentation revealed unsatisfactory performance for analyte Lymphocytes (%) in the second and third testing events of 2018. Refer to D2130. 4. Available laboratory documentation included no evidence of investigation or