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: Based on record review and staff interview, the testing personnel and the laboratory director failed to attest to performing hematology, mycology, and parasitology proficiency testing (PT) in the same manner as routine patient samples in two of three events in 2017. Findings include: 1) Review on 8/21/2018 of microscopy procedure PT records from 2017 (three events) for fern test, semen analysis, potassium hydroxide slide preparation (KOH prep), and saline wet mount slide examination (wet mount) revealed the laboratory director failed to sign the attestation form for the first event in 2017 and the one testing personnel who performed the microscopy procedures failed to sign the attestation form for the second event. 2) Interview on 8/21 /2018 at 10:15 a.m. with the laboratory manager/testing personnel confirmed above finding. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of mycology and parasitology testing at least twice in 2017. Findings 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 -- include: 1) Review on 8/21/2018 of proficiency testing (PT) records from 2017 for wet mount preparation (wet mount) testing revealed the laboratory failed to obtain an acceptable score for one (of one) PT samples tested in the first event and for one (of one) PT sample in the third event. 2) Interview on 8/21/2018 at 10:15 a.m. with the laboratory manager/testing personnel confirmed the above finding. The laboratory manager revealed the laboratory did not perform any other testing to verify the accuracy of wet mount testing in 2017. 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 record review and staff interview, the laboratory failed to evaluate the unacceptable proficiency testing (PT) result for wet mount preparation in the first PT event of 2017. Findings include: 1) Review on 8/21/2018 of PT records from 2017 (three events) revealed the laboratory failed to obtain an acceptable result for wet mount testing for one (of one) PT sample in the first event of 2017. Review of the "Performance Review and