Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on document review and interview with laboratory personnel, the laboratory failed to test Hematology proficiency testing samples in the same manner it tests patient specimens. Findings are as follows: 1. The laboratory performed proficiency testing (PT) through the American College of Physicians Medical Laboratory Evaluation (MLE) program. 2. The laboratory tested hematology proficiency testing samples from the 2017 MLE-M1 event on multiple days as indicated on the test reports obtained from the Abbott Cell-Dyn Emerald hematology analyzer. See below Sample Test date 1 Test date 2 HD-2 02/13/17 02/16/17 HD-5 02/13/17 02/16/17 3. In an interview on 03/05/19 at 2:30 p.m., the Laboratory Director confirmed the above finding and indicated patient specimens would not be tested in this manner. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. 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 -- This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing (PT) records for at least 2 years. Findings are as follows: 1. The laboratory performed proficiency testing (PT) through the American College of Physicians Medical Laboratory Evaluation (MLE) program. 2. The MLE PT attestation statement for the 2018 MLE-M2 event was not present in laboratory records on date of survey. The laboratory was unable to provide this document upon request. 3. In an interview on 03/05/19 at 2:30 p.m., the Laboratory Director confirmed the 2018 MLE-M2 event attestation statement was not retained. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate an unacceptable Microbiology proficiency testing (PT) result for 1 analyte in 2017. Findings are as follows: 1. The laboratory performed proficiency testing (PT) through the American College of Physicians Medical Laboratory Evaluation (MLE) program. 2. The laboratory received an unacceptable PT result in the 2017 MLE-M3 event for the analyte listed below. Sample Test Lab MLE result K- 5 KOH* absent present 3. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 4. In an interview on 03/05/19 at 11:30 a. m., the Laboratory Director confirmed a documented investigation of the unacceptable result was not performed. * Note KOH - Potassium Hydroxide D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)